Condition category
Circulatory System
Date applied
08/03/2005
Date assigned
04/04/2005
Last edited
14/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlos Brotons

ORCID ID

Contact details

Unit of Research
Sardenya Primary Health Care Center
Sardenya 466
Barcelona
08025
Spain
+34 935 67 43 80
cbrotons@eapsardenya.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PREseAP

Study hypothesis

A comprehensive programme on secondary prevention of cardiovascular diseases in primary care reduces rehospitalisation and mortality, and improves quality of life.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular disease

Intervention

Health Centres (clusters) are randomised to intervention or control group.

Intervention group (comprehensive programme in secondary prevention led by well-trained registered nurses):
Patient education and counselling, optimisation of the treatments according to CVD prevention guidelines (drugs, diet, exercise). The number of scheduled visits will be 9 (every 4 months).

Control group:
Patients in the control group will be assigned to conventional care. Number of visits: two (baseline assessmenta and final visit at the end of the trial).

Follow-up period: 3 years
Endpoints: combined of cardiovascular disease mortality and cardiovascular disease morbidity (including revascularisation)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2100

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Unit of Research
Barcelona
08025
Spain

Sponsor information

Organisation

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

Sponsor details

Sardenya 466
Barcelona
08025
Spain
+34 935 67 43 80
cbrotons@eapsardenya.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-Ministerio de Sanidad y Consumo) (Spain) (ref: PI031421)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18361907

Publication citations

  1. Results

    Orozco-Beltrán D, Brotons C, Moral I, Soriano N, Del Valle MA, Rodríguez AI, Pepió JM, Pastor A, , [Factors affecting the control of blood pressure and lipid levels in patients with cardiovascular disease: the PREseAP Study]., Rev Esp Cardiol, 2008, 61, 3, 317-321.

Additional files

Editorial Notes