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

NCT02244853 | Unknown

• 3 other identifiers: 12_153R_IP24086091/Z/08/ZRP-PG-0407-10314
• Study Type: observational
• Target: 51,703
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An open cohort of 2,23 million people covering approximately 5% of the UK population was drawn from registrants to 225 GP practices who consented to data linkage.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Wellcome Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Farr Institute, University College London

London, NW1 2DA, United Kingdom

Location

MeSH Terms

Conditions

Angina, Stable; Myocardial Infarction; Coronary Disease; Heart Failure; Stroke; Death, Sudden, Cardiac; Peripheral Arterial Disease; Atrial Fibrillation; Hemorrhage

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Arrest; Death, Sudden; Death; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Arrhythmias, Cardiac

Study Officials

• Harry Hemingway, Professor

  Farr Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

GB (1)