Effects of ‘plate model’ as a part of dietary intervention on rehabilitation of post myocardial infarction patients.

Not Applicable

Recruiting

• Conditions: Post myocardial infarction rehabilitation

• Registration Number: SLCTR/2016/022
• Lead Sponsor: Institute of Cardiology, National Hospital of Sri Lanka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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 < 8.0 g/dl for both men and women).

2. Pregnancy or breast feeding.

3. Any documented infection with systemic effects; i.e. developed high grade fever, Abnormal leucocyte count> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. A mean reduction in body weight in the test group compared to the control group. <br><br>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) <br><br> [At baseline (visit 0), at completion of 4 weeks (follow-up 1), at completion of 12 weeks (follow-up 2)]<br>

Secondary Outcome Measures

Name	Time	Method
1. Mean reduction of systolic (SBP) and diastolic blood pressure (DBP)<br>2. BMI<br>3. Waist circumference (WC)<br>4. Hip circumference (HC)<br>5. Fasting blood glucose<br>6. Serum ALT level <br>7. Total and LDL cholesterol<br>8. Mean increment of HDL cholesterol level <br><br>For the intervention group only:<br><br>9. Qualitative assessment of the knowledge, perception, and attitudes (KPA) regarding the ‘plate model’ diet (1 hour focus group discussions and in-depth interviews)<br><br> [Outcomes 1-6: At baseline (visit 0), at completion of 4 weeks (follow-up 1) and at completion of 12 weeks (follow-up 2).<br><br>Outcomes 7- 8: At baseline (visit 0), and at completion of 12 weeks (follow-up 2).<br><br>Outcome 9: At 4 weeks (until data saturation is achieved).<br><br>]<br>