Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study
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|ClinicalTrials.gov Identifier: NCT01164371|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : May 12, 2016
|Condition or disease|
|Coronary Disease Cardiovascular Disease|
The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome, or unheralded coronary death. Gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease are not well understood. Furthermore, while the management of coronary risk factors in primary care is hypothesized to play a key role in the rate and timing of such transitions, little is known about the impact such management has on gender differences these transitions and outcomes.
- To determine gender differences in probabilities of transitions from symptom-free state to mortality for each of three patient coronary disease pathways, where the initial disease manifestation is angina, myocardial infarction or unheralded coronary death.
- To determine the role management of coronary risk factors in primary care has in explaining any gender differences in transitions from symptom-free state to mortality for each of the three patient coronary disease pathways.
A statistical analytic protocol for the first part of this study, comparing patients with unheralded coronary death to patients free of symptomatic coronary disease, dated June 2010, is available on request. A second statistical analytic protocol for the second part of this study, comparing initial presentation of coronary disease, within a framework of competing risks of atherosclerotic disease, dated December 2011, is available on request.
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 Type :||Observational|
|Actual Enrollment :||1758584 participants|
|Official Title:||Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2013|
Initial presentation of coronary disease - Stable angina
Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms)
Initial presentation of coronary disease - ACS
Patients whose initial symptomatic presentation of coronary disease is acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI [nSTEMI] or unstable angina) without prior stable angina or symptoms of stable angina
Initial presentation of coronary disease - Coronary death
Patients whose initial symptomatic manifestation of coronary disease is coronary death with no prior diagnosis of stable angina (or symptoms of stable angina) or diagnosis of acute coronary syndrome
Initial presentation of coronary disease - None
Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause
- coronary mortality (ICD 10 I20-I25) [ Time Frame: up to 15 years from entry into cohort ]coronary mortality, following symptom free state, diagnosed angina or acute coronary syndrome
- stable angina [ Time Frame: up to 15 years from entry into cohort ]diagnosis of angina following symptom free state
- acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina [ Time Frame: up to 15 years from entry into cohort ]acute coronary syndrome following either symptom-free state (unheralded) or stable angina
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164371
|Principal Investigator:||Julie George, MSc||University College, London|