Effects of a nurse coordinated program of lifestyle improvement aimed at reducing the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome.;RESPONSE2: (Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2)
Withdrawn
- Conditions
- atherosclerosiscardiovascular diseases1001108210024450
- Registration Number
- NL-OMON37248
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
age 18-80 years
hospitalized for an acute coronary syndrome less than 8 weeks before inclusion ,
at least one of the following lifestyle related risk factors:
- Smoking (including smoking of any tobacco product in the 6 months preceding hospitalisation).
- BMI*27 kg/m2
- Physical activity below recommended levels (5 times 30 minutes/week)
Exclusion Criteria
- visits to the prevention programs not feasible
- not available for follow-up
- surgery, percutaneous coronary intervention or other interventions expected within 8 weeks after inclusion
- limited life expectancy (*2 years)
- New York Heart Association class III or IV heart failure
- Beck's Depression Inventory (BDI) score of *10
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following parameters are compared between the intervention group and the<br /><br>control group at 12 months:<br /><br>* Smoking status (binary, non-smoking is defined as urinary cotinine < 200<br /><br>ng/ml)<br /><br>* Body Mass Index (kg/m2)<br /><br>* 6 Minute Walking Distance (meters)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison between baseline and 12 months of:<br /><br>* Smoking status (urinary cotinine < 200 ng/ml)<br /><br>* Body Mass Index (kg/m2)<br /><br>* Waist circumference (cm)<br /><br>* 6 Minute Walking Distance (meters)<br /><br>2. The following parameters are compared between the intervention group and the<br /><br>control group at 12 months:<br /><br>* fasting serum LDL levels (mmol/L)<br /><br>* systolic blood pressure (mmHg)<br /><br>* incidence of newly diagnosed diabetes mellitus<br /><br>* control of existing diabetes mellitus (fasting blood glucose and plasma HbA1c<br /><br>levels)<br /><br>* body composition (fat and muscle mass by impedance scales)<br /><br>* hospital readmission rates<br /><br>* signs of depression (Beck*s Depression Inventory)</p><br>