Prognostic Models for People With Stable Coronary Artery Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT01609465
First received: May 22, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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
Stable Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Models for People With Stable Coronary Artery Disease

Further study details as provided by University College, London:

Estimated Enrollment: 300000
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable angina

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 22, 2012
Last Updated: May 29, 2012
Health Authority: United Kingdom: Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014