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Randomised controlled trial to assess the efficacy of a comprehensive secondary prevention programme in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18578323
Enrollment
2100
Registered
2005-04-04
Start date
2005-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Circulatory System Coronary heart disease, stroke, peripheral vascular disease

Interventions

Health Centres (clusters) are randomised to intervention or control group. Intervention group (comprehensive programme in secondary prevention led by well-trained registered nurses): Patient educatio

Sponsors

Sardenya Primary Care Center (in collaboration with the Catalan Foundation Institute of Pharmacology) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1. Combination of total mortality 2. Cardiovascular fatal events 3. Cardiovascular non-fatal events

Secondary

MeasureTime frame
1. Total mortality 2. Cardiovascular fatal events 3. Cardiovascular non-fatal events 4. Quality of life measured with the 36-item short form health survey (SF-36) instrument

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026