Acute Myocardial Infarction (STEMI/ NSTEMI) Clinical Trial
Official title:
Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
| Verified date | December 2014 |
| Source | IRCCS Policlinico S. Matteo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
Results after interventions on lifestyle in the secondary prevention of ischemic heart
disease are not always consistent, and the Guidelines multidisciplinary measures aren't
easily achievable.
Therefore, the purpose of this research project is the identification of an interventional
approach to effective secondary prevention and realistic feasibility, in a field of
multifactorial risk. The study is open to patients who totaled a double chronic disease,
obesity/overweight and coronary heart disease, and who experienced a first event of ischemic
cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational
intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first
episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic
approach of prescriptive diet therapy.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | December 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: Subjects of both sexes and age = of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9. Exclusion Criteria: Patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Cardiology department | Pavia | |
| Italy | Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation | Pavia | PV |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Policlinico S. Matteo |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | reduction of body weight | The proportion of subjects with a 10% reduction in body weight at 6 months | 6 months | No |
| Secondary | Reduction of reinfarction and revascularization | 1 year | No | |
| Secondary | general and specific mortality | relative risk of death from all causes and from ischemic heart disease (no. of overall deaths and cardiovascular causes). | 1 year | No |
| Secondary | quality of life | quality of life (assessed by SF-36 questionnaire at baseline and 6 months after infarction). | 6 months | No |