Randomized clinical trial to assess the efficacy of an intervention to reduce the cardiovascular risk by improving the information given to patients

Not Applicable

Completed

• Conditions: People at high cardiovascular risk; Circulatory System; High cardiovascular risk

• Registration Number: ISRCTN18383298
• Lead Sponsor: Biomedical Research Institute Sant Pau

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33807285/ (added 17/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-06
• Study Completion: 2019-12-31
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1. Both gender
2. 40- 69 years old
3. Fulfilling at least one of the following criteria
3.1. High cardiovascular risk (SCORE =5% and/or REGICOR =10%)
3.2. SCORE relative risk >= 4
3.3. Diabetes with proteinuria or a major risk factor (smoking, dyslipidaemia or hypertension)
4. Severe kidney chronic disease (GFR < 30 mL/min/1.73 m2)
5. Subclinical Atherosclerosis

Exclusion Criteria

1. Patients with established cardiovascular disease
2. Life expectancy of less than 1 year
3. Mental disease limiting patient’s self-care capability
4. Drug and/or alcohol abuse
5. Already enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular risk is measured using the SCORE system as well as REGICOR tool at baseline and at one-year, at the end of the trial

Secondary Outcome Measures

Name	Time	Method
<br> 1. Physical exercise is measured using IPAQ (International Physical Activity questionnaire) at baseline and at the end of the trial<br> 2. Diet is measured using Mediterranean Diet Score at baseline and the end of the trial<br> 3. Tobacco measured using a specific questionnaire collecting information on number of cigarrtes at baseline and at the end of the trial<br> 4. Blood lipids are measured using blood tests at baseline and at the end of the trial<br> 5. Blood pressure is measured using a semi-automatic digital blood pressure monitor at baseline and at the end of the trial<br> 6. Weight is measured using a digital weighing scale at baseline and at the end of the trial<br> 7. BMI is measured using heght and weight (Kg/m2) at baseline and at the end of the trial<br>