Risultati per: Standard di qualità sulla Fibrillazione Atriale

Introduction
Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis
The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.
The trial will be delivered by a multidisciplinary research team through a series of five work packages.
The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination
The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number
ISRCTN13296529.

Circulation, Volume 148, Issue Suppl_1, Page A19151-A19151, November 6, 2023. Introduction:Recurrent pericarditis is defined as the recurrence of pericarditis after a symptom-free interval of 4-6 weeks. Our study aimed to investigate the improvement in the late gadolinium enhancement on cardiac resonance imaging (CMR) in recurrent patients on IL-1 blockers and standard anti-inflammatory therapy.Hypothesis:We hypothesize that patients on IL-1 inhibitor show a better improvement of LGE on CMR in recurrent pericarditis.Methods:This is a retrospective comparative cohort study of 37 recurrent pericarditis patients on IL-1 inhibitor and 107 recurrent pericarditis patients on standard anti-inflammatory therapy. We included patients with LGE tracing and compared both groups. Patients were treated for at least 12 months and were followed for a duration minimum of 12 months.Results:The patients’ mean age in the IL-1 inhibitor group was 51.16 ±16, and the standard therapy group was 54.26 ± 14.32. Patients had a median baseline ESR of 5 mm/hr and median hs-CRP of 2.2 mg/L in the IL-1 inhibitor group and a median baseline ESR of 7.5 mm/hr and median hs-CRP of 1.5 mg/L in the standard therapy group. At baseline, patients in the IL-1 inhibitor group had 5.4% none LGE, 43.24% mild LGE, 37.83% moderate LGE, and 13.5% severe LGE. Over the follow-up of 12-24 months, IL-1 inhibitor patients had improvement in LGE, with 35.13% of patients having none LGE and 64.86% having mild LGE. In the standard group, 27.1% had none LGE, 54.2% had mild LGE, 15.88% had moderate LGE, and 2.8% had severe LGE at baseline. Over 12-24 months follow-up, standard therapy group patients had some improvement as well as worsening of LGE in some patients, with 35.51% having none LGE, 59.81% having mild LGE, and 4.6% having moderate LGE.Conclusions:IL-1 inhibitors serve as a competitive antagonist of IL-1 cytokine and block its pro-inflammatory functions. Pericardial delayed enhancement is significant in determining disease course and improvement in patients with pericarditis.

Circulation, Volume 148, Issue Suppl_1, Page A13881-A13881, November 6, 2023. Introduction:Recent publications have reported that myocardial infarction (MI) patients (pts) without standard modifiable risk factors (SMuRF-less) are surprisingly common (14-27%) and have a notable risk of adverse outcomes. These reports raise the question of how these pts can be identified in advance and provided with effective preventive therapies (e.g., statins, aspirin).Methods:Pts presenting between 2001-2021 to Intermountain Healthcare catheterization laboratories with a diagnosis of MI were included if they also had a coronary artery calcium scan (CACS) by computed tomography within 2 years. SMuRF included a clinical diagnosis of, or treatment for, hypertension, hyperlipidemia, diabetes, and/or smoking. The co-primary endpoints for this study were the proportion of patients with an elevated ( >50%ile) CACS score (MESA criteria) and the presence of an indication for statin therapy with or without aspirin (i.e., >=75%ile score or CAC >=100 AU). Major adverse cardiovascular event (MACE) outcomes at 60-days and long-term were evaluated and compared to MI pts with SMuRF.Results:We identified 429 MI pts with a concurrent CACS, of which 60 were SMuRF-less and 369 had SMuRF. The 2 groups were similar in age, sex, most risk factors, and interventions, but fewer SMuRF-less pts had a history of heart failure or a family history (Table 1). SMuRF-less pts had a high prevalence and an increased percentile of CAC (82% >=50%ile; median, 80%ile;), and 77% met criteria for preventive therapy. Pts with SMuRF, as expected, had high CAC scores and percentiles (Table 1). Outcomes were more favorable for SMuRF-less status (Table 2A) and for lower CAC scores (Table 2B).Conclusions:Despite absence of SMuRF, SMuRF-less pts presenting with an MI have a high prevalence and percentile of CAC. Wider application of CACS, to include those without SMuRF, appears promising as a method to identify an additional at-risk population for consideration of preventive therapy.

Circulation, Volume 148, Issue Suppl_1, Page A17703-A17703, November 6, 2023. Introduction:Hypertension increases cardiovascular risk. Measuring reliable blood pressure (sBP and dBP for systolic and diastolic BP) is challenging. A photoplethysmography (PPG)-based wristband with a custom BP algorithm could provide continuous BP. The algorithm was made by PPG channel aggregation, band-pass filtering and segment creation and evaluated the different PPG colors. Noise and interference were removed. PPG segments were created with a quality factor based on pulse quality. The AI model learned patterns from structured data, including pre-processed features and initialization measurements, ranking their importance.Hypothesis:cuffless PPG-based-wristband method for continuous BP monitoring is compatible with ISO 81060-2:2019.Methods:Compare PPG-guided BP algorithm predictions with subclavian arterial reference measurements during cardiac catheterization. Consecutive patients meeting ISO 81060-2:2019 criteria were included. Reference measurements used a validated invasive BP device (100Hz). PPG signals were collected at 128Hz using six light emission diodes and two photodiodes. Three initialization measurements with a validated cuff were taken before catheterization. Machine learning-based BP algorithm utilized 100+ features. Correlation, mean error, and standard deviation (SD) and sBP and dBP were determined.Results:97 patients provided 420 samples. Mean age, weight, and height were 67 years, 183.7 lbs, and 5’8.5″ respectively. sBP swas ≤100mmHg (11%) and ≥160mmHg (25%). dBP was ≤70mmHg (53%) and ≥85mmHg (24%). BP algorithm predictions correlated strongly with reference measurements for sBP (r = 0.985) and dBP (r = 0.961) BP. Mean error was ±3.7mmHg (SD 4.4 mmHg) for sBP and ±2.5mmHg (SD 3.7 mmHg) for dBP. Results were consistent across gender and skin color categories (Fitzpatrick I-VI), but also for different strata of BP values.Conclusions:Wristband-based PPG with the developed BP algorithm provides accurate continuous BP monitoring across various BP ranges. It offers a valid and less burdensome alternative to cuff BP measurements for in-hospital and at-home monitoring. Further research is needed to evaluate algorithm precision during movement and for long-term prediction stability.

Circulation, Volume 148, Issue Suppl_1, Page A17590-A17590, November 6, 2023. Background:The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that intensive systolic blood pressure (SBP) lowering was associated with marked reductions in cardiovascular disease (CVD) endpoints. We recently reported that intensive SBP lowering was also associated with a small increase in high-sensitivity cardiac troponin T (hs-cTnT) and a large decrease in N-terminal pro-B-type natiuretic peptide (NT-proBNP) over 1-year. However, data on longer term biomarker changes with intensive versus standard SBP lowering have not been previously reported.Methods:hs-cTnT and NT-proBNP were measured at baseline, 1 year, and 2 years from stored specimens in SPRINT participants. Changes in biomarkers were evaluated continuously on the log scale with interval censoring of participants with CVD events. The effect of intensive SBP lowering on biomarker changes was assessed using linear regression models with treatment effects reported as geometric mean ratios.Results:Of 9,361 SPRINT participants, hs-cTnT and NT-proBNP were measured in 8,828 (baseline), 7,887 (Year 1), and 7,463 (Year 2) free of CVD events. Intensive SBP lowering led to a 3% increase in log-transformed hs-cTnT from baseline to Year 1, but there was no significant change observed from baseline to Year 2. In contrast, intensive SBP lowering led to a consistent 10% decrease in NT-proBNP from baseline to Year 1 and to Year 2. NT-proBNP levels increased slightly from Year 1 to Year 2 in both treatment arms such that the 1-Year treatment effect for intensive SBP lowering was maintained to Year 2 (see Table).Conclusions:Intensive SBP lowering was associated with a transient, modest increase in hscTnT at Year 1 that was no longer present at Year 2. In contrast, intensive SBP lowering was associated with a persistent reduction in NT-proBNP at both 1 and 2 years follow-up. These findings highlight the complex responses of cardiac biomarkers to intensive SBP lowering.

Circulation, Volume 148, Issue Suppl_1, Page A13349-A13349, November 6, 2023. Background:While the acute exposure to electronic cigarette (e-C) vapor has been associated with an increase in blood pressure, the chronic effect of e-C vapor on blood pressure compared to standard cigarette smoke has not been extensively studied. We determined the effect of chronic e-C exposure versus standard cigarette smoke on blood pressure and other cardiac functional measures.Methods:Sprague Dawley rats (both sexes) were randomly exposed to air (n=34), e-C with nicotine (e-Cn; n=30), e-C without nicotine (e-C; n= 28) or standard cigarette smoke (SCS; n=27) for 12 weeks. After 12 weeks of exposure hemodynamics were determined by Millar catheter, echocardiography, and thermodilution catheter, a few days after their last exposure.Results:As shown in the Table, SCS was associated with higher systolic, diastolic and mean blood pressures and peak LV systolic pressure compared to air or e-Cn or e-C groups. Neither fractional shortening or cardiac output differed among the groups. dp/dt min, a measure of diastolic LV function, was lowest in the e-C group. Tau, a measure of LV relaxation was worse in this group as well.Conclusions:Standard cigarette smoke exposure was associated with an increase in blood pressure when blood pressure was tested at 12 weeks. Neither electronic cigarette smoke with or without nicotine caused an increase in blood pressure compared to air. However, e-C was associated with worse diastolic function. Standard cigarettes may be associated with a greater sympathetic surge causing elevated blood pressure compared to electronic cigarettes.

Circulation, Volume 148, Issue Suppl_1, Page A14701-A14701, November 6, 2023. Background:Handheld echocardiography (echo) is the tool of choice for Rheumatic Heart Disease (RHD) screening, based on the 2012 World Heart Federation (WHF) Criteria. We aimed to assess the agreement between screening and standard echo for diagnosis of latent RHD in schoolchildren from an endemic setting.Methods:Over 14 months, 3 non-physicians used handheld machines (GE, VSCAN) and the 2012 WHF Criteria to determine RHD prevalence in low-income public schools in Minas Gerais, Southeast Brazil. Consented children were eligible for participation. Studies were interpreted remotely using a telemedicine cloud-server by 2 experts in Brazil and the US. RHD-positive children (borderline and definite) and those with congenital heart disease (CHD) were referred for standard echo with portable devices (GE, Vivid IQ), with acquisition and interpretation by an expert cardiologist. Agreement between screening and standard echo, by category and according to the WHD criteria, was assessed, and the kappa statistic was applied.Results:A total of 1,390 students were screened in 6 schools and, among these, 110 (7.9%, 95% CI 6.5 – 9.5) were screen-positive and referred for standard echo, with mean age of 14±2 years, 80 (72%) women. Among the 16 cases initially diagnosed as definite RHD, 11 (69%) were confirmed, 4 (25%) reclassified to borderline and 1 to normal. Among the 79 cases flagged as borderline RHD, 19 (24%) were confirmed, 50 (63%) reclassified to normal, 8 (10%) to definite RHD and 2 had mild CHD. Among 11 children with CHD in screening, 4 were confirmed, 5 were reclassified to normal and 2 to RHD. Considering the 4 diagnostic categories, kappa was 0.18. In patients with borderline RHD reclassified to non-RHD, the most frequent WHF criteria was B (isolated mitral regurgitation): 64%, followed by A (2 morphological features of the mitral valve): 31%. In the only patient with definite RHD reclassified to normal, WHF criteria was D (borderline RHD in aortic and mitral valves). After standard echo, RHD prevalence was 3.2% (95% CI 2.3 – 4.2).Conclusions:Although practical, RHD screening with handheld devices tend to overestimate prevalence. Even in endemic settings, continuous education for detection, and application of risk stratification for management are crucial.

Circulation, Volume 148, Issue Suppl_1, Page A14724-A14724, November 6, 2023. Background:Prior studies examining patients who experienced acute myocardial infarction (AMI) as their initial presentation of coronary disease have shown that those without Standard Modifiable Risk Factors (SMuRF; diabetes, dyslipidemia, hypertension, and smoking) had worse in-hospital but better long-term survival than those with SMuRFs. However, the health status outcomes, patients’ symptoms, function, and quality of life among those without SMuRF are unknown.Research questions:Are there differences in long-term health status and mortality between patients who survived hospitalization following AMI with and without SMuRFs?Methods:We analyzed data from two prospective registries, PREMIER and TRIUMPH, comprising patients hospitalized to 31 US hospitals with AMI between 2003-2008. We compared the clinical characteristics, 1-year health status (with the Seattle Angina Questionnaire [SAQ]), and 5-year all-cause mortality between patients with and without SMuRFs. Patients with prior coronary artery disease were excluded. We used hierarchical linear mixed models for health status outcomes and Cox-proportional hazard models for mortality, adjusted for clinical and sociodemographic characteristics, including baseline SAQ scores.Results:Among 4076 patients with AMI (mean age 58.4±12.4 years, 34% female, 22% Black), 569 (13.9%) presented without SMuRFs. Despite similar mean age, patients without SMuRFs were more likely to be male, Non-Hispanic White, have higher income and education, fewer depressive symptoms, and higher SAQ Summary Scores at baseline (83.5±13.2 vs. 79.6±16.5). At 1-year follow-up, patients without SMuRFs had higher SAQ Summary Scores (93.9±10.1 vs. 89.9±14.7), although the difference between groups was attenuated after adjustment (1.69 points, 95% CI 0.40-1.97). Furthermore, there were no significant differences in all-cause mortality over 5 years between groups (adjusted HR= 0.83, 95% CI: 0.59-1.16). Notably, besides sex or race category, a higher incomes and better depression status were negative independent predictors for health status and clinical outcomes.Conclusions:AMI survivors, both with and without SMuRFs, had comparable long-term health status and survival after rigorous adjustment.

Circulation, Volume 148, Issue Suppl_1, Page A12720-A12720, November 6, 2023. Introduction:The association between the duration of cardiopulmonary resuscitation (CPR) and patient outcomes remains largely unknown.Hypothesis:long-term CPR (LCPR) may benefit certain group of patients.Methods:In this retrospective cohort study, data from the Chinese Emergency Triage Assessment and Treatment database 1.0 (CETAT 1.0) were utilized. The study included CA patients admitted to 14 teaching hospitals in 7 provinces between July 2015 and July 2020. Patients were categorized into SCPR and LCPR groups based on the duration of resuscitation, where SCPR referred to CPR duration less than 60 mins, and LCPR referred to CPR duration equal to or more than 60 mins. The primary outcome measured was ROSC rates between the two groups, while the secondary and tertiary outcomes was 24-hour and 7-day survival rates. A multivariate logistic regression model was employed to analyze the factors influencing ROSC between groups.Results:A total of 529 patients were enrolled in the study, with 372 in the SCPR group and 157 in the LCPR group. Among them, 126 (33.9%) patients in the SCPR group and 56 (35.7%) in the LCPR group achieved ROSC without statistically difference between groups. Furthermore, 31 patients (8.3%) in the SCPR group and 7 patients (4.5%) in the LCPR group survived at 24 hours, while 13 patients (3.5%) in SCPR and 4 patients (2.5%) in LCPR group survived at 7 days, both without statistical difference. Factors associated with SCPR operation included Lower BMI, previous hypertension, daytime admission, hands-only compression, and ventilation. SpO2 and PETCO2 were independent factors associated with ROSC, Moreover, in both groups higher SpO2 and PETCO2 levels were associated with a higher rate of ROSC, suggesting that for this specific patient cohort, longer duration of CPR should be considered.Conclusions:Longer duration of CPR may need to be emphasize for certain group of patients, particularly those with high SpO2 and PET CO2 during CPR.

Circulation, Volume 148, Issue Suppl_1, Page A306-A306, November 6, 2023. Background:Just-in-time (JIT) video training has been proposed as an alternative to in-person CPR courses, with associated time and cost savings.Research Question:Does a JIT training video improve layperson performance of CPR?Aim:Measure CPR performance using a JIT video compared to the American Heart Association (AHA) HeartSaver® CPR AED Training course.Methods:A convenience sample of laypeople was randomized to perform CPR in a simulated scenario a) after participating in an AHA HeartSaver® course led by experienced instructors, b) with access to a JIT training video, or c) control, with no assistance or training. CPR quality was assessed by trained evaluators and objective performance assessed using Laerdal QCPR-enabled simulators. The primary outcome was performance of correct CPR.Results:Of 230 eligible subjects, 226 were randomized with no significant differences in baseline characteristics across groups. Prevalence of correct CPR was low, though significantly higher in the AHA group (AHA: 40%, 95%CI 28-51; JIT: 15%, 95%CI 8-26; control 10%, 95%CI 4-19). Overall, 94% of participants performed compressions within 1 minute, with no difference between groups. An AED was called for more frequently in the AHA group (47%) than the JIT (15%) or control (10%) groups. Flow fraction was significantly better in the AHA group (89%, IQR 77-99) compared to the JIT (75%, IQR 47-90) or control (49%, IQR 22-74) groups and compression rates of 100-120 were more frequent in the AHA (51%) and JIT groups (47%) compared to controls (27%).Conclusions:While correct performance of specific CPR skills varied in this sample, laypersons using a JIT training video performed as well as those taking an AHA HeartSaver® course on several key measures such as rapid chest compression and compression rate. JIT video training may be a viable option for supporting untrained bystander CPR performance, though further evaluation is needed to identify optimal strategies for implementation.

Circulation, Volume 148, Issue Suppl_1, Page A242-A242, November 6, 2023. Background:Multiple biomarkers have been used in prognostication of outcome after out-of-hospital cardiac arrest (OHCA) and standard cardiopulmonary resuscitation (CPR). Limited evidence exists for patients resuscitated with extracorporeal CPR (ECPR). We hypothesized that (1) the time course and (2) prognostic performance of biomarkers will differ between CPR and ECPR.Methods:This is a pre-planned sub-analysis of Prague-OHCA study. Patients were randomized to either CPR or ECPR. The primary outcome was poor neurologic outcome at 180 days, defined as a cerebral performance category (CPC) of 3-5. Secondary outcomes included assessment of biomarkers of neurologic injury (NSE), inflammation (procalcitonin – PCT, C-reactive protein – CRP, neutrophil-lymphocyte ratio – NLR) and hematology (platelets – Plt, D-dimers – D-dim, and fibrinogen – Fg) using Mann-Whitney test with Bonferroni correction, and ROC analysis of data at 24-72 h.Results:In as-treated analysis, ECPR was used in 92 patients. The primary outcome was not different between groups: CPR, CPC 1-2 48 (29.3%) vs CPC 3-5 116 (70.7%); ECPR, CPC 1-2 20 (21.7%) vs CPC 3-5 72 (78.3%); p= 0.191. In general, individual biomarkers exhibited similar trajectories over 72 h, with worse values in patients with CPC 3-5 in both CPR and ECPR groups. PCT was higher in ECPR group at 24-72 h (all p

Circulation, Volume 148, Issue Suppl_1, Page A415-A415, November 6, 2023. Introduction:Circumferential constriction CPR (CC-CPR) applied by pneumatic vest may be superior to standard sternal compression, and the addition of alternative pumping modalities may further enhance efficacy. Interposed abdominal counterpulsation (IAC-CPR) CC-CPR is one such modality. Early canine studies of IAC reported greater efficacy when the abdominal counterpulsation was started 30% before the thoracic compression, rather than fully counterphase timing as is used clinically. This may be thought of as “Abdominal Preload” IAC (Pre-CPR).Hypothesis:Addition of IAC-CPR to CC-CPR may be associated with improved perfusion pressures, and Pre-CPR may be even more effective.Methods:We compared CC-CPR to IAC-CPR and Pre-IAC in a porcine model of VF (n=6). In IAC-CPR, the constrictions are fully counterphase. In Pre-IAC, abdominal constriction is initiated 30% before thoracic constriction. Alternating 30 second epochs of each treatment were applied via a circumferential abdominal vest. Aortic (Ao) and Right Atrial (RA) pressures were measured by micromanometer catheters. IAC-CPR and Pre-CPR end-epoch pressures were each compared to preceding CC-CPR end-epoch pressures.Results:Addition of IAC-CPR and Pre-IAC to CC-CPR were both associated with similar, significant increases in CPPs. However, the source of these improvements differed (See Table 1). For IAC-CPR, the increase appeared to result from an Ao increase greater than an associated increase in RA. For Pre-CPR, the increase appeared to be solely due to increased Ao.Limitations:Small sample. Surrogate biomarkers. Non-human model.Conclusions:The addition of pulsatile abdominal counter-constriction to vest CC-CPR may be a promising path to multimodality, regardless of the particulars of cycle timing. We do not confirm earlier observations that Pre-CPR may be superior to IAC-CPR.

Circulation, Volume 148, Issue Suppl_1, Page A16773-A16773, November 6, 2023. Introduction:Lp(a) is a robust predictor of coronary heart disease outcomes, with targeted therapies currently under investigation. However, there is a paucity of data regarding the risk of elevated Lp(a) in relation to other cardiovascular risk factors.Objective:To evaluate the association of high Lp(a) with standard modifiable risk factors (SMuRFs) for incident first acute myocardial infarction (AMI).Methods:This retrospective study utilized the MGB Lp(a) Registry which included patients ≥18 years with an Lp(a) measurement between 2000-2019. Exclusion criteria were severe kidney dysfunction, malignant neoplasm, and prior known atherosclerotic cardiovascular disease (ASCVD). Diabetes mellitus, hyperlipidemia, hypertension, and smoking were considered SMuRFs. High Lp(a) was defined as >90thpercentile and low Lp(a) as

Circulation, Volume 148, Issue Suppl_1, Page A14207-A14207, November 6, 2023. Introduction:Artificial intelligence (AI) using electrocardiogram (ECG) enabled to predict atrial fibrillation (AF) in patients without documented AF. It needs 12-lead ECG with tremendous data learning. Mobile 1-lead ECG is more convenient to surveil cardiac rhythm with simple measurement. However, AI-enabled arrhythmia predictability by mobile ECG is limited due to single channel utilization and longer duration for arrhythmia diagnosis.Hypothesis:We aimed to enhance mobile ECG AF prediction AI algorithm integrated with 12-lead ECG deep learning model.Methods:Based on 552,372 12-lead ECG data of 318,321 patients, a statistical AF prediction model employing a deep-learning approach was constituted. The raw data of 6,792 1-lead mobile ECGs were acquired from 6,792 patients for about 1 minute at 250Hz. A statistical AF prediction model with mobile ECG employing a deep-learning approach was constituted. Resnet structure was utilized to distinguish subtle changes of the vicinity of P-wave. Both 12-lead ECG and mobile ECG were allocated to training, validation, testing datasets in a 6:2:2 ratio. Then, we conducted transfer learning using the standard 12-lead ECG’s deep learning model to improve performance of 1-lead mobile ECG deep learning model.Results:AF was annotated in 26,541 (4.8%) with 12-lead ECG whereas 1,443 (21.2%) with 1-lead mobile ECG. The area under the curve (AUC) value for predicting AF was 0.910 with 12-lead ECG, and 0.721 with mobile ECG . The predictive performance of mobile ECG was 79.7% in accuracy, 47.5% in sensitivity and 50.3% in F1-score. The AUC value of mobile ECG after applying transfer learning based on 12-lead ECG for AF prediction was increased to 0.905 with accuracy of 89.1%, sensitivity of 71.3% and F1-score of 57.7%.Conclusions:Integration with deep learning algorithm of standard 12-lead ECG significantly improved the model performance of mobile ECG AF prediction model compared to 1-lead mobile ECG only based model. Easy application of mobile ECG with enhanced AF predictability might serve a more convenient method as a pre-emptive assistive tool to provide probabilistic prediction for PAF screening rather than 12-lead ECG.

Introduction
Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

Methods and analysis
The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

Ethics and dissemination
The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number
German Clinical Trials Register (DRKS00029323).