Assessment of Lesion-Associated Myocardial Ischemia Based on Fusion Coronary CT Imaging- the FUSE-HEART Study: Protocol for a Non-randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MACE rate-Major Adverse Cardiovascular Events
研究概览
简要总结
The aim of the Fused-Heart study is to investigate the impact of a coronary artery stenosis on myocardial function and viability, based on advanced fusion imaging techniques derived from CCTA.
Moreover the study will investigate the correlation between morphology and composition of atheromatous plaques located in a coronary artery and myocardial ischemia in the territory irrigated by the same coronary artery.
详细描述
The FUSE-HEART study is a prospective, observational, single-center, cohort study that will be conducted in the Laboratory of Advanced Research in Cardiac Multimodal Imaging of Cardio Med Medical Center Targu Mures, Romania.
The study will include 100 subjects with coronary lesions depicted by CCTA examination. The study population will consist in: (1) patients with anatomically significant coronary lesions (at least 50% luminal narrowing) on native coronary arteries, or (2) patients surviving an acute myocardial infarction, revascularized or not. In all patients, presence of vulnerability features in the atheromatous plaques will be studied and the vulnerability score will be calculated for each plaque, consisting in one point added for each of the following vulnerability markers: positive remodeling, napkin-rink sign, presence of low density plaque or spotty calcium within the plaque. In addition, following 3D fusion of the images of the coronary tree with the images reflecting wall motion, the correspondence between plaque morphology and composition on one hand, and wall motion in the corresponding distribution territory of that coronary artery, will be studied based on fused models.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, with a projected recruitment period of 1 year and will be followed-up 1 year for MACE.
Study objectives:
Primary: to investigate the impact of a coronary artery stenosis on myocardial function and viability, based on advanced fusion imaging techniques derived from CCTA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing CCTA examination, with at least one coronary artery lesion producing a luminal narrowing >50%
- •Ability to provide informed consent;
- •Patients aged at least 18 years;
排除标准
- •Unwillingness or incapacity to provide informed consent;
- •Allergy to contrast media;
- •Absolute or relative contraindications to CCTA imaging;
- •Irregular or rapid heart rhythm
- •Pregnancy or lactation;
- •Women with childbearing potential in absence of any contraceptive treatment;
- •Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
- •Active malignancy or malignancy within the last 5 year prior to enrollment;
- •Conditions associated with an estimated life expectancy of under 2 years;
结局指标
主要结局
MACE rate-Major Adverse Cardiovascular Events
时间窗: 12 months
The primary outcome of the study is represented by the rate of MACE events related to myocardial ischemia at 1-year post assessment, in correlation with the degree of coronary artery stenosis and myocardial ischemia or viability.
次要结局
- Re-hospitalisation rate,(12 months)
- Rate of survival(12 months)