Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

Sponsor

University College, London (Other)

Overall Status

Completed

CT.gov ID

NCT01804439

Collaborator

(none)

2,240,000

Enrollment

157.9

Duration (Months)

Study Details

Study Description

Brief Summary

Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.

Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.

We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Cardiovascular Diseases Acute Myocardial Infarction Unstable Angina Chronic Stable Angina Ischemic Stroke Cerebrovascular Accident Subarachnoid Hemorrhage Transient Ischemic Attack Abdominal Aortic Aneurysm Peripheral Arterial Disease Sudden Coronary Death Ventricular Arrhythmia Sudden Death Cardiac Arrest Heart Failure

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2240000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data

Study Start Date :

Jan 1, 1997

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
CALIBER Healthy Cohort We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).

Arm

Intervention/Treatment

CALIBER Healthy Cohort

We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).

Outcome Measures

Primary Outcome Measures

First presentation of cardiovascular disease, as specified in description [Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).]
First occurrence of the following fatal or non-fatal cardiovascular outcomes: acute myocardial infarction, unstable angina, stable angina, ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, sudden cardiac death, heart failure

Secondary Outcome Measures

Non CVD specific deaths [Same as for primary outcomes (maximum of 13 years after follow-up start)]
Death from non CVD, that is, excluding deaths related to the primary endpoints.

Other Outcome Measures

Cardiovascular heart disease and fatal cardiovascular disease [Same as for primary endpoint (maximum of 13 years after follow-up start)]
Cardiovascular heart disease: combination of MI and unheralded coronary death. Cardiovascular disease: combination of fatal cardiovascular heart disease and stroke of any type. Fatal cardiovascular disease: combination of fatal coronary heart disease and fatal cardiovascular death.