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Prognostic Models for People With Stable Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT01609465
Recruitment Status : Unknown
Verified May 2012 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

There is currently no published algorithm for secondary prevention prognosis of CHD that is representative of the England GP-registered population and that includes both symptomatic and asymptomatic patients (as identified through primary care). In this paper the investigators will exploit routinely collected information in clinical practice to model CHD prognosis based on a large contemporary open cohort of stable CAD patients. Although the investigators model is based on data from GP practices in England only, the investigators believe that this population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background, predisposing characteristics and lifestyles to generate a prognostic model with good generalizing power to the wider population.

Among the research questions the investigators will try to answer is whether established risk factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also reliable for risk-stratification of patients who have already developed CAD. Similarly, the investigators will examine whether strong predictors of adverse outcomes in ACS patients in the short term, such as admission SBP and heart rate, are also associated with their long term prognosis.


Condition or disease
Stable Coronary Artery Disease

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 300000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Models for People With Stable Coronary Artery Disease
Study Start Date : January 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Stable angina


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

To define incident cases we will exclude patients who have not been observed during the year prior to their CAD diagnosis date. For prevalent cases we will remove this condition.

Our startpoint population is defined as patients aged 18 years or over diagnosed with CAD, under which we include:

  1. patients diagnosed with stable angina
  2. patients with ACS (STEMI, NSTEMI & unstable angina) who survived > 4 weeks. Patients with a CAD diagnosis who received revascularization during follow-up will enter the cohort after the procedure (given post-procedure survival >4 weeks).
Criteria

Inclusion Criteria:

  • Eligible general practices were defined as practices that meet standards for acceptable levels of data recording (i.e. audits demonstrated that "at least 95% of relevant patient encounters are recorded and data meet quality standards for epidemiological research"7), and have consented to linkage with HES and MINAP (approximately 200 practices).
Contacts and Locations

Information from the National Library of Medicine

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): NCT01609465


Locations
United Kingdom
Clinical Epidemiology Group, UCL
London, United Kingdom, WC1E 7HE
Sponsors and Collaborators
University College, London
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Harry Hemingway, FRCP University College, London
More Information

Publications:

Responsible Party: Harry Hemingway, Professor of Clinical Epidemiology, University College, London
ClinicalTrials.gov Identifier: NCT01609465     History of Changes
Other Study ID Numbers: CALIBER 10-13
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Harry Hemingway, University College, London:
CAD
stable angina
STEMI
NSTEMI
CVD
secondary prevention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases