Prognostic Models for People With Stable Coronary Artery Disease
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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 |
| 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 |
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:
- patients diagnosed with stable angina
- 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).
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| United Kingdom | |
| Clinical Epidemiology Group, UCL | |
| London, United Kingdom, WC1E 7HE | |
| Principal Investigator: | Harry Hemingway, FRCP | University College, London |
More Information
Additional 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 May 19, 2013