A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Prognostic impact of resting resistances
研究概览
简要总结
The evidence above demonstrates that microvascular dysfunction is an important determinant of patient prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear definition for this disease has a potentially large clinical importance. It is important to better describe the phenotype of these patients, identify the predictors of prognosis, and determine the impact of diagnosis.
详细描述
The study is designed as prospective registry. Patients with angina CCS II-IV undergoing assessment of microvascular function will be enrolled.
The study does not interfere with the medical standards at the sites with regards to patient treatment or follow-up care.
Study duration and schedule The duration of this study is expected to be 7 years. The subject recruitment is planned to start in January 2020 and end in January 2022. The actual overall study duration or subject recruitment period may differ from these time periods. Per-patient, the duration of participation will be up to 5 years. Patients will be evaluated at hospital discharge, at 12 months and 5 years (the latter two as telephone contacts).
Number of subjects and study centers It is planned to enroll 1000 subjects in the registry based on power calculations as described. Recruitment and treatment of subjects is expected to be performed in 10 study centers.
Primary endpoint The primary endpoint is the composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure, and unplanned coronary angiography at 12 months.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and <85 years.
- •Chronic coronary syndrome (including patients with anginal equivalents)
- •Angina CCS class II-IV
- •Evidence of reversible ischemia on non-invasive testing
- •Availability of the following measurements:
- •Index of microvascular resistances (IMR),
- •Resting full-cycle ratio (RFR),
- •Fractional flow reserve (FFR),
- •Coronary flow reserve (CFR)
- •Willingness to participate and ability to understand read and signed the informed consent document before the procedure
排除标准
- •At least one of the following:
- •Pregnancy and or lactation.
- •Medical or psychological conditions that would jeopardize an adequate and orderly participation.
- •Left ventricular ejection fraction lower than 30%
- •Previous coronary artery bypass surgery (CABG) to all major branches in the LAD and left circumflex (LCX) territory, such that IMR cannot be measured
- •Decompensated congestive heart failure (CHF)
- •Chronic or acute renal failure with creatinine >2mg/dl
- •Severe valvular heart disease
- •Patients with comorbidities limiting life expectancy to less than one year
结局指标
主要结局
Prognostic impact of resting resistances
时间窗: 12 months
The impact of resting resistances (expressed as Mean Transit Time, i.e. time for a saline bolus to reach the wire thermistor times distal pressure) on the incidence of patient-oriented outcomes (composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure and unplanned coronary angiography) at 12 months
次要结局
- Correlation between physical ability and IMR(6 months, 1 year and yearly to 5 years.)
- Distribution of aortic and distal pressure(At inclusion)
- Correlation between depression and IMR(6 months, 1 year and yearly to 5 years.)
- Distribution of mean transit time (Tmn)(At inclusion)
- Distribution of index of microvascular resistances (IMR)(At inclusion)
- Correlation between SAQ measures and IMR(6 months, 1 year and yearly to 5 years.)
研究者
Tommaso Gori
Clinical Professor
Johannes Gutenberg University Mainz