Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study

May 11, 2016 updated by: Julie George, University College, London

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

The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Objectives:

  1. 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.
  2. 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

Enrollment (Actual)

1758584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include all adults aged 35 or over in General Practice Research Database (GPRD), registered with an up-to-standard practice with at least 1 year of continuous follow-up.

Further details on defining up-to-standard practices within GPRD are available from http://www.gprd.com/home/

Description

Inclusion Criteria:

  • as above

Exclusion Criteria:

  • patients with a history of ischaemic heart disease, heart failure, cerebrovascular disease, peripheral arterial disease or congenital coronary anomalies, prior to entry into the cohort
  • patients with symptoms of chest pain in the 6 months prior to cohort entry
  • patients < 35 or >100 years of age after eligibility for entry to the cohort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 15 years from entry into cohort

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stable angina
Time Frame: up to 15 years from entry into cohort
diagnosis of angina following symptom free state
up to 15 years from entry into cohort
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
up to 15 years from entry into cohort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

London School of Hygiene and Tropical Medicine
Barts and the London School of Medicine and Dentistry

Investigators

  • Principal Investigator: Julie George, MSc, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALIBER-09-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Permissions to used anonymised linked data from data owners prohibit further sharing of the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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