Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease

• Conditions: Myocardial Infarction; Coronary Heart Disease; Atrial Fibrillation; Stroke; Bleeding; Stable Angina; Death, Sudden, Cardiac; Heart Failure; Peripheral Arterial Disease

• Registration Number: NCT02244853
• Lead Sponsor: University College, London

Brief Summary

The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

Detailed Description

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 51703

Inclusion Criteria

• Aged >=30 years at study entry ->=1 year registration prior to the 'index date'

Exclusion Criteria

• Free from previous atherosclerotic events
• No heart rate measurement after their 'index date' of eligibility to entry the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease	expected average of 3 years	Participants were followed until their first cardiovascular or complication event after their studyentry and after at least one previous cardiovascular event. Hazard ratios will be presenting associations between heart rate (analysed as quintiles and as continuous per 10bpm) and 8 different cardiovascular diseases (including mortality outcomes, complications such as bleeding events and composite cerebrovascular and coronary heart disease endpoints).

Trial Locations

Locations (1)

Farr Institute, University College London; 🇬🇧 London, United Kingdom