Primary Objective: To determine the effectiveness of a comprehensive lifestyle intervention program aimed at reducing the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome.Secondary Objective:…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following parameters are compared between the intervention group and the
control group at 12 months:
* Smoking status (binary, non-smoking is defined as urinary cotinine < 200
ng/ml)
* Body Mass Index (kg/m2)
* 6 Minute Walking Distance (meters)
Secondary outcome
Comparison between baseline and 12 months of:
* Smoking status (urinary cotinine < 200 ng/ml)
* Body Mass Index (kg/m2)
* Waist circumference (cm)
* 6 Minute Walking Distance (meters)
2. The following parameters are compared between the intervention group and the
control group at 12 months:
* fasting serum LDL levels (mmol/L)
* systolic blood pressure (mmHg)
* incidence of newly diagnosed diabetes mellitus
* control of existing diabetes mellitus (fasting blood glucose and plasma HbA1c
levels)
* body composition (fat and muscle mass by impedance scales)
* hospital readmission rates
* signs of depression (Beck*s Depression Inventory)
Background summary
The RESPONSE 1 trial demonstrated that a practice oriented, hospital-based
nurse coordinated prevention program on top of usual care leads to an important
reduction in the risk of recurrent events in patients who have been
hospitalised for an acute coronary syndrome. Most of this improvement was
achieved by better control of targets for drug treatment, including blood
pressure and serum lipids. In contrast, lifestyle changes were not achieved,
particularly smoking cessation, increases in physical exercise or weight loss.
Study objective
Primary Objective: To determine the effectiveness of a comprehensive lifestyle
intervention program aimed at reducing the risk of recurrent cardiovascular
events in patients who have suffered an acute coronary syndrome.
Secondary Objective: improvement in blood pressure, cholesterol and glucose
levels, reduction in hospitalization, newly diagnosed diabetes mellitus
Study design
Multicenter, prospective randomised controlled trial
Intervention
On top of usual care, the intervention group will receive a comprehensive,
modular, tailored lifestyle intervention, involving the partner where
appropriate, using e-health support and referral to existing commercial
programs for weight reduction (Weight Watchers®), physical exercise
(DirectLife®, Philips) and smoking cessation (local facilities).
Study burden and risks
no experimental treatments are performed during the study
Main burdes are time investment and discomfort in taking of blood samples,
blood pressure, weight, length, waist hip ratio.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTTC=1290 |
| CCMO | NL41645.018.12 |