Post myocardial infarction rehabilitation
Conditions
Interventions
Study site: Institute of Cardiology, National Hospital of Sri Lanka.
Method of recruitment and allocation into the study arms:
Subjects will be voluntary participants who are admitted to Unit I,II,I
Sponsors
Institute of Cardiology, National Hospital of Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 20 years to 70 years 2. The patients who developed acute coronary event(STEMI, NSTEMI) regardless of the history of unstable angina, STEMI defined as new ST elevation at the J point in at least 2 contiguous leads of ?2 mm (0.2 mV) in men or ?1.5 mm (0.15 mV) in women in leads V2–V3 and/or of ?1 mm (0.1 mV) in other contiguous chest leads or the limb leads , New or presumably new LBBB, NSTEMI is diagnosed in the absence of above ECG changes although in the presence of cardiac biomarker positivity (according to ACC/ AHA guidelines) 3. Troponin I >0.5 ng/ml and CK-MB > 5.0 ng/ml. The diagnosis is made by the admitting medical officer and before recruiting the patient the investigator will also confirm the presence of above criteria. 4. Diagnosis of acute coronary event within the past 1 month. 5. Patients who are eating homemade rice for main meals at least two times a day. 6. Patients who consume rice for at least two main meals a day. 7. Patients who are able to attend to clinic follow-ups in a monthly basis. 8. Patients whose BMI is more than 23 kgm-2
Exclusion criteria
Exclusion criteria: 1. End stage renal failure (stage III or more), Congestive cardiac failure (NYHA class III and above), Chronic liver cell disease ( Child- Pugh score class B or more) Severe anaemia (Haemoglobin 11,000/microliter, or ESR > 22mm/1st hour for men and 29mm/1st hour for women, within last 2 weeks. 4. Patients who are already on a modified diet or dietary supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A mean reduction in body weight in the test group compared to the control group. Venous blood sample will be attempted to collect within 24 hours following the admission by which time the lipids are expected not to change due to acute MI (ACC/AHA Class I recommendation) [At baseline (visit 0), at completion of 4 weeks (follow-up 1), at completion of 12 weeks (follow-up 2)] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean reduction of systolic (SBP) and diastolic blood pressure (DBP) 2. BMI 3. Waist circumference (WC) 4. Hip circumference (HC) 5. Fasting blood glucose 6. Serum ALT level 7. Total and LDL cholesterol 8. Mean increment of HDL cholesterol level For the intervention group only: 9. Qualitative assessment of the knowledge, perception, and attitudes (KPA) regarding the ‘plate model’ diet (1 hour focus group discussions and in-depth interviews) [Outcomes 1-6: At baseline (visit 0), at completion of 4 weeks (follow-up 1) and at completion of 12 weeks (follow-up 2). Outcomes 7- 8: At baseline (visit 0), and at completion of 12 weeks (follow-up 2). Outcome 9: At 4 weeks (until data saturation is achieved). ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr.Ranil Jayawardena MBBS, MSc, PhD.
Senior Lecturer
Outcome results
None listed