Coronary Disease Clinical Trial
— PTCA-NutriOfficial title:
Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial
Verified date | December 2009 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
The simple knowledge that practices healthy lifestyle are important to reduce or prevent the
progression of cardiovascular diseases it is not enough for effective changes accordingly.
To nutritional education be successful, needs to promote changes in eating habits and not
just transmit information. This is a behavioral intervention study in 200 consecutive
patients submitted to percutaneous transluminary coronary angioplasty. The participants were
randomized in two groups: intervention and control.
The intervention was a dialogic nutritional counseling and the control arm was a traditional
nutritional counseling.
All participants will undergo long-term follow-up for cardiovascular events.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | January 2012 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - preserved cognitive status Exclusion Criteria: - no availability to attend the meetings of nutritional guidance |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes) | 1 year (all outcomes) and 3 years (all outcomes) | No | |
Secondary | - Evaluate changes in eating habits, according to the transtheoretical model to adopt healthy eating habits - Check change in food intake - Identify the nutritional status and cardiovascular risk | 1 year | No |
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