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

Stroke Clinical Trial

Official title:

Association of Heart Rate With Cardiovascular Disease Prognosis of Patients With Stable Coronary Artery Disease: A CALIBER Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02244853
• Other study ID #: 12_153R_IP24
• Secondary ID: 086091/Z/08/ZRP-
• Status: Active, not recruiting
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 18, 2014
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51703
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina, Stable
• Atrial Fibrillation
• Bleeding
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Death, Sudden
• Death, Sudden, Cardiac
• Heart Failure
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina
• Stroke

Locations

Country	Name	City	State
United Kingdom	Farr Institute, University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease	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).	expected average of 3 years	No