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

The University of Sydney0 个研究点目标入组 150 人开始时间: 2020年11月3日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•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

•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

发起方