Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

Stroke Clinical Trial

Official title:

Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01947361
• Other study ID #: 12_153R_IP10
• Secondary ID: RP-PG-0407-10314
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2013
• Last updated: September 17, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2013
• 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

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

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: 1961286
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiac Arrest, Sudden Cardiac Death
• Cardiovascular Diseases
• Cerebral Hemorrhage
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease NOS
• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Diseases
• Heart Failure
• Hemorrhage
• Intracerebral Haemorrhage
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stable Angina Pectoris
• Stroke
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage
• Transient Ischemic Attack
• Unheralded Coronary Death
• Unstable Angina

Locations

Country	Name	City	State
United Kingdom	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 atherosclerotic disease in patients with high or low heart rate	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.)	Participants were followed until the first Coronary disease event (an expected average of 5 years)	No
Secondary	Incidence proportions and life time risk for Cardiovascular diseases	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	Participants were followed until the first Coronary disease event (an expected average of 5 years)	No

External Links

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