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

Multicentre, randomised, open clinical trial to assess the efficacy of an intervention to reduce the cardiovascular risk by improving the information given to patients at high cardiovascular risk

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18383298

Enrollment

1256

Registered

2018-02-06

Start date

2016-10-01

Completion date

Unknown

Last updated

2021-06-28

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

Conditions

People at high cardiovascular risk Circulatory System High cardiovascular risk

Interventions

The intervention consists of explaining cardiovascular risk in a more comprehensive way including figures, in terms of absolute risk, relative risk and vascular age. Randomization (1:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Spain

Contacts

Public ContactCarlos Brotons

Outcome results

None listed

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