ISRCTN14603929进行中（未招募）未知
Super Rehab”: Can we achieve coronary artery disease regression? (a feasibility study)
Royal United Hospital Bath NHS Trust0 个研究点目标入组 43 人开始时间: 2022年1月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-080735 (added 13/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/10/2022:
- •1. 18 - 75 years of age
- •2. Confirmed coronary artery disease on CT coronary angiography, with at least one coronary artery with plaque affecting =25% of the lumen, and evidence of coronary inflammation (defined by an abnormal fat attenuation index (FAI) of > -70.1HU or with FAI score [relative to age and sex matched patients] = 75th percentile in the left anterior coronary or right coronary artery or with FAI score = 90th percentile in the circumflex artery)
- •3. Have Metabolic Syndrome, defined as meeting any 3 of the following within 6 months of their cardiac CT: high abdominal waist circumference (=94cm males, =80cm females), hypertension (=130/85mmHg or on treatment), raised fasting glucose or HbA1c (glucose =5.6mmol/L, HbA1c =42mmol/L or on diabetic treatment), low HDL (=1mmol/L males, <1.3mmol/L females), and high triglycerides (>1.7mmol/L)
- •4. Able and willing to safely comply with all study procedures
- •5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study
- •Previous inclusion criteria:
- •1. 18 - 75 years of age
- •2. Confirmed coronary artery disease on CT coronary angiography, with at least one coronary artery with plaque affecting =25% of the lumen, and evidence of coronary inflammation, as defined by an abnormal fat attenuation index of >-70.1HU
- •3. Meet streamlined criteria for identification of metabolic syndrome, including a high body mass index of >28 kg/m2, and abnormal blood glucose control (defined as HbA1c >42 mmol/mol / >6%)
- •4. Able and willing to safely comply with all study procedures
- •5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study
排除标准
- •1. Prognostic coronary artery disease, defined as left main stem >50% stenosis, flow-limiting disease in the proximal left anterior descending artery, or at least moderate disease in =3 major epicardial vessels
- •2. Unstable angina
- •3. New York Heart Association class III/IV heart failure or severe left ventricular impairment
- •4. Significant cardiomyopathy (as assessed by a cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
- •5. Severe heart valve disease
- •6. Severe hypertension (BP >180/120 mmHg) despite optimising anti-hypertensive therapy
- •7. Uncontrolled cardiac arrhythmia or higher degree heart block
- •8. History of aortic dissection
- •9. Recent acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack
- •10. Severe autonomic or peripheral neuropathy
- •11. Acute systemic illness of fever
- •12. Significant acute or chronic renal failure
- •13. Pulmonary fibrosis or interstitial lung disease
- •14. Physically unable to participate in high-intensity exercise
- •15. A history of prior heart attack or coronary re-vascularisation (entitled to existing cardiac rehabilitation)
- •16. Severe coronary calcification precluding assessment of the coronary lumen on CT coronary angiography
- •17. A clinically significant ECG abnormality at the screening visit, which in the opinion of the investigators exposes the subject to risk by enrolling in the trial
- •18. Pregnant or breastfeeding
- •19. Participation in another intervention-based research study
- •20. Inability to fully understand the instructions provided during the study
研究者
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