A randomised controlled trial to evaluate an intensive lifestyle program for reversal of coronary heart disease.

Not Applicable

Recruiting

• Conditions: Cardiovascular - Coronary heart disease; Coronary Heart Disease

• Registration Number: ACTRN12620001151921
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-03
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Presence of LAP on coronary CTA
• 18-80 years of age
• BMI greater than or equal to 22.0 kg/m2
• Able to give full informed consent
• Able to undergo all study evaluations and adhere to the rigors of the ILP intervention

Exclusion Criteria

• History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer that, in opinion of the investigator, would make the candidate ineligible for the study
• Non-MRI-compatible implanted devices or implants
• Estimated glomerular filtration rate (eGFR) less than 30mL/kg/1.73m2
• Inability to exercise via supine ergometer
• Claustrophobia
• Contraindications for adenosine: Sinus node disease (e.g. sick sinus syndrome, symptomatic sinus bradycardia), second- or third- degree heart blocks, unstable angina, bronchospasm (e.g. asthma), heart transplant recipient, history of seizure disorder
• Contraindications for glyceryl trinitrate: Known nitrate hypersensitivity, severe anaemia, severe aortic or mitral stenosis, hypotension defined as resting systolic blood pressure equal to 89 mmHg.
• Not suitable for CT coronary angiography due to contraindications
• Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder)
• Breast feeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention
• Unwilling to be assigned at random to the ILP+OMT or OMT group
• Unwilling or unable to adhere to the rigors of the ILP intervention or evaluation schedule over the entire one-year period
• Concurrent participation in any other interventional study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Low-attenuation plaque volume (mm3) at 12 months with respect to baseline level using CT angiography. [ Baseline and at 12 months after randomisation.];Change in Myocardial blood flow (ml/g/min) at 12-month with respect to baseline level using MRI. [ Baseline and at 12 months after randomisation]