Protocol for the OPTIMSE-1 randomised clinical trial to test specialist-led identification and management of cardio-renal-metabolic-pulmonary disease in machine learning algorithm-detected high-risk community-dwelling individuals.

Introduction: People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

Methods And Analysis: OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care.

PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial.

Background: Randomized clinical trials from over 20 years ago demonstrated that an implantable cardioverter defibrillator (ICD) improved survival for patients with severely reduced left ventricular ejection fraction (LVEF) after myocardial infarction (MI) compared with optimal medical therapy (OMT) alone. Since then advances in therapy have led to the reduction in the incidence of sudden cardiac death (SCD) in this population, whilst complication rates from ICD implantation are still substantial.

Objectives: To determine whether OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality.

Effectiveness of the GRACE risk score according to troponin elevation in patients admitted with non-ST elevation acute coronary syndrome: a post hoc analysis of the UKGRIS parallel group cluster randomised controlled trial.

Background: The effectiveness of risk stratification using the Global Registry of Acute Coronary Events (GRACE) Risk Score (GRS) for patients presenting to hospital with suspected non-ST elevation acute coronary syndrome (NSTEACS) according to troponin elevation is unknown.

Methods: Post hoc analysis of a phase 3 parallel group cluster randomised controlled trial (UK GRACE Risk Score, UKGRIS) of adult patients presenting with suspected NSTEACS to 42 hospitals in England between 9 March 2017 and 30 December 2019, with hospitals randomised (1:1) to standard care or according to the GRS and associated guidelines. Coprimary outcome measures were use of guideline-recommended management and time to the composite of cardiovascular death, non-fatal myocardial infarction, new-onset heart failure hospitalisation or readmission for cardiovascular event at a minimum of 24 months follow-up.

Outcome measures for randomised clinical trials and multicentre observational studies of cardiovascular diseases published in major clinical journals: systematic review and evidence mapping.

Background: Outcome measure choice and definition can determine the result of the study. We describe outcome measures and their definitions for cardiovascular studies in highly cited medical journals.

Methods: Cardiovascular phase III or IV randomised clinical trials (RCTs) or multicentre observational studies published in the , or between 1 January 2013 and 6 June 2024 from Embase and Ovid Medline were included.

Identification, characterisation and outcomes of pre-atrial fibrillation in heart failure with reduced ejection fraction.

Aims: Atrial fibrillation (AF) in heart failure with reduced ejection fraction (HFrEF) has prognostic implications. Using a machine learning algorithm (FIND-AF), we aimed to explore clinical events and the cardiac magnetic resonance (CMR) characteristics of the pre-AF phenotype in HFrEF.

Methods And Results: A cohort of individuals aged ≥18 years with HFrEF without AF from the MATCH 1 and MATCH 2 studies (2018-2024) stratified by FIND-AF score.

Systematic screening for atrial fibrillation with non-invasive devices: a systematic review and meta-analysis.

Background: Systematic screening individuals with non-invasive devices may improve diagnosis of atrial fibrillation (AF) and reduce adverse clinical events. We systematically reviewed the existing literature to determine the yield of new AF diagnosis associated with systematic AF screening, the relative increase in yield of new AF diagnosis with systematic screening compared to usual care, and the effect of systematic AF screening on clinical outcomes compared with usual care.

Methods: The Medline, Embase, Web of Science and Cochrane Library databases were searched from inception through 1st February 2025 for prospective cohort studies or randomised clinical trials (RCTs) of systematic AF screening with the outcome of incidence of previously undiagnosed AF from screening.

Impact of neighbourhood and environmental factors on the risk of incident cardiovascular disease: a systematic review and meta-analysis.

Aims: We aimed to study the association of five key neighbourhood exposures in large cohort studies and risk of incident cardiovascular disease (CVD).

Methods: We conducted a systematic search of MEDLINE, The Cochrane Library, Web of Science, and Embase from database inception to 20th October 2024. Included studies reported both incident (first-time) CVD diagnosis and neighbourhood exposures across five domains: retail environment; health services; physical environment; pollution; and neighbourhood deprivation.

Identification and management of cardiopulmonary risk in patients with COPD: a multidisciplinary consensus and modified Delphi study.

Background: Cardiovascular disease is a common comorbidity in chronic obstructive pulmonary disease (COPD). Yet cardiovascular disease and risk is under diagnosed in COPD and is often undertreated, increasing the risk of cardiopulmonary events.

Methods: We formed a Global Working Group of experts in COPD and cardiovascular disease to produce a consensus statement detailing the identification and management of cardiopulmonary risk in patients with COPD.

Perceptions of healthcare professionals on the use of a risk prediction model to inform atrial fibrillation screening: qualitative interview study in English primary care.

Objectives: There is increasing interest in guiding atrial fibrillation (AF) screening by risk rather than age. The perceptions of healthcare professionals (HCPs) towards the implementation of risk prediction models to target AF screening are unknown. We aimed to explore HCP perceptions about using risk prediction models for this purpose, and how models could be implemented.

Prediction of atrial fibrillation after a stroke event: A systematic review with meta-analysis.

Background: Detecting atrial fibrillation (AF) after stroke is a key component of secondary prevention, but indiscriminate prolonged cardiac monitoring is costly and burdensome. Multivariable prediction models could be used to inform selection of patients.

Objective: This study aimed to determine the performance of available models for predicting AF after a stroke.

Empirical investigation of multi-source cross-validation in clinical ECG classification.

Traditionally, machine learning-based clinical prediction models have been trained and evaluated on patient data from a single source, such as a hospital. Cross-validation methods can be used to estimate the accuracy of such models on new patients originating from the same source, by repeated random splitting of the data. However, such estimates tend to be highly overoptimistic when compared to accuracy obtained from deploying models to sources not represented in the dataset, such as a new hospital.

Association of baseline and changes in health-related quality of life with mortality following myocardial infarction: multicentre longitudinal linked cohort study.

Background: Health-related quality of life (HRQoL) for patients following myocardial infarction (MI) is frequently impaired. We investigated the association of baseline and changes in HRQoL with mortality following MI.

Methods And Results: Nationwide longitudinal study of 9474 patients admitted to 77 hospitals in England as part of the Evaluation of the Methods and Management of Acute Coronary Events study.

Presentation, care, coronary intervention and outcomes of patients with NSTEMI according to age: insights from the international prospective ACVC-EAPCI EORP NSTEMI registry.

Background: Older people less frequently receive invasive coronary angiography (ICA) for NSTEMI than younger patients. We describe care, ICA data, and in-hospital and 30-day outcomes of NSTEMI by age in a contemporary and geographically diverse cohort.

Methods: Prospective cohort study including 2947 patients with NSTEMI from 287 centres in 59 countries, stratified by age (≥75 years, n = 761).

Prediction of incident chronic kidney disease in community-based electronic health records: a systematic review and meta-analysis.

Background: Chronic kidney disease (CKD) is a major global health problem and its early identification would allow timely intervention to reduce complications. We performed a systematic review and meta-analysis of multivariable prediction models derived and/or validated in community-based electronic health records (EHRs) for the prediction of incident CKD in the community.

Methods: Ovid Medline and Ovid Embase were searched for records from 1947 to 31 January 2024.

Risk calculator for incident atrial fibrillation across a range of prediction horizons.

Background: The increasing burden of atrial fibrillation (AF) emphasizes the need to identify high-risk individuals for enrolment in clinical trials of AF screening and primary prevention. We aimed to develop prediction models to identify individuals at high-risk of AF across prediction horizons from 6-months to 10-years.

Methods: We used secondary-care linked primary care electronic health record data from individuals aged ≥30 years without known AF in the UK Clinical Practice Research Datalink-GOLD dataset between January 2, 1998 and November 30, 2018; randomly divided into derivation (80%) and validation (20%) datasets.