The AUSMED Heart Trial: The Australian Mediterranean diet trial for secondary prevention of heart disease

Not Applicable

Recruiting

• Conditions: Coronary Heart Disease; Cardiovascular Disease; Type 2 Diabetes; Diet and Nutrition - Other diet and nutrition disorders; Cardiovascular - Coronary heart disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000156482
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

Eligible participants will be high risk cardiology patients who have experienced a cardiac event with acute presentation to The Northern Hospital or St Vincent's Hospital. Cardiac event includes participants who have suffered an acute myocardial infarction (AMI) (stemi or non-stemi infarct), angina pectoris or have had coronary artery bypass surgery (CABG), balloon angioplasty (with or without stent). Participants will also be included if they have type 2 diabetes or metabolic syndrome.

Exclusion Criteria

Exclusion criteria includes participants that: are non-English speaking, have active malignancy, chronic heart failure, chronic inflammatory disease (e.g. Inflammatory bowel disease, Rheumatoid arthritis, renal failure or on dialysis, liver disease), Body mass index (BMI) >40kg/m2, are currently breastfeeding or pregnant, currently participating in an intervention targeting diet or exercise, inability to attend the counselling sessions or examinations, inability to complete the six month dietary intervention due to medical, cultural, social, religious factors or food allergies/intolerances that prevent them from consuming the intervention foods.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac endpoints (Acute Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty, cardiovascular mortality, all-cause mortality) measured via self-report, hospital medical records and death registry. [Across 12 months from the beginning of the intervention. ]