Randomised controlled trial to assess the efficacy of a comprehensive secondary prevention programme in primary care
- Conditions
- Cardiovascular diseaseCirculatory SystemCoronary heart disease, stroke, peripheral vascular disease
- Registration Number
- ISRCTN18578323
- Lead Sponsor
- Sardenya Primary Care Center (in collaboration with the Catalan Foundation Institute of Pharmacology) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2100
Patients are recruited from 42 primary health care centres from eight different regions of Spain (2100 patients are expected to be recruited).
Inclusion Criteria:
Males and females below 86 years, diagnosed with coronary heart disease (CHD), stroke or peripheral vascular disease in the last year.
1. Patients diagnosed with cardiovascular disease (CVD) before the year 2004
2. Unstable patients (post myocardial infarction [MI] angina of less than 28 days after discharge, ventricular arrhythmias in the last six months)
3. Subarachnoid haemorrhage, cerebral embolisms secondary to valve disease
4. Patients with concomitant serious chronic disease (cancer, chronic renal failure, etc.)
5. Patients with poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Combination of total mortality<br>2. Cardiovascular fatal events<br>3. Cardiovascular non-fatal events
- Secondary Outcome Measures
Name Time Method 1. Total mortality <br>2. Cardiovascular fatal events<br>3. Cardiovascular non-fatal events<br>4. Quality of life measured with the 36-item short form health survey (SF-36) instrument