Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

• Conditions: Abdominal Aortic Aneurysm; Coronary Heart Disease NOS; Unheralded Coronary Death; Intracerebral Haemorrhage; Heart Failure; Ischemic Stroke; Myocardial Infarction; Stroke; Peripheral Arterial Disease; Stable Angina Pectoris

• Registration Number: NCT01947361
• Lead Sponsor: University College, London

Brief Summary

Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.

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: 2012-01
• Status Verified: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Study First Posted: 2013-09-20
• Last Update Posted: 2013-09-20
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1961286

Inclusion Criteria

• One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
• > 30 years old
• have at least a recorded heart rate measurement during the study period

Exclusion Criteria

• Evidence of prior atherosclerotic or cardiac disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of atherosclerotic disease in patients with high or low heart rate	Participants were followed until the first Coronary disease event (an expected average of 5 years)	Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by: * by sex; * gender; * a range of risk factors (such as physical activity, smoking status, drinking status, etc.)

Secondary Outcome Measures

Name	Time	Method
Incidence proportions and life time risk for Cardiovascular diseases	Participants were followed until the first Coronary disease event (an expected average of 5 years)	Subhazard Ratios and Cumulative Incidence estimation of the risk of 12 different cardiovascular diseases adjusted for the 4 different levels of heart rate (\<60, 60-74, 75-89, \>90), age and sex in a lifetime period

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom