Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

March 3, 2013 updated by: Harry Hemingway, University College, London

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2240000

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

30 years and older (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 patients aged ≥30yrs old, registered in CPRD practices in England consenting to data linkage, with at least 1 year of up-to-standard pre-study follow-up and no history of any of the CVD endpoints considered. Follow-up for endpoints will commence on the earliest date on which a patient fulfils the criteria, within the period between 1st January 1997 and 25th March 2010.

Description

Inclusion Criteria:

  • Aged ≥30yrs old
  • Registered in CPRD practices in England consenting to data linkage
  • ≥1 year of up-to-standard pre-study follow-up

Exclusion Criteria:

  • History of any of the CVD endpoints considered before study follow-up initiation.

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: Prospective

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First presentation of cardiovascular disease, as specified in description
Time Frame: 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
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non CVD specific deaths
Time Frame: 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.
Same as for primary outcomes (maximum of 13 years after follow-up start)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular heart disease and fatal cardiovascular disease
Time Frame: 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.
Same as for primary endpoint (maximum of 13 years after follow-up start)

Collaborators and Investigators

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

Sponsor

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

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

January 1, 1997

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

March 3, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 3, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALIBER 12_153R

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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