Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Coronary flow (mL/min) in the LAD
研究概览
简要总结
Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be severe by angiography may cause limited ischemia (with an FFR value >0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass.
Therefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI.
In a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the STEMI group:
- •ST segment elevation MI ≥7 days treated by angioplasty of the left anterior descending (LAD) artery
- •Scheduled to undergo angiography for fractional flow reserve (FFR) assessment of a lesion other than the infarct-related artery.
- •Inclusion criteria for the control group:
- •patients undergoing non-urgent coronary angiography for stable angina or silent ischemia
- •with measure of the FFR on one or more vessels (intermediate lesion <90% without proven ischemia)
- •absence of any significant lesion on the LAD (as assessed by angiography or FFR>0.8)
- •Inclusion criteria for both groups:
- •Written informed consent
- •Affiliation to a social security regimen (or beneficiary thereof).
排除标准
- •Target vessel (LAD) not permeable.
- •FFR <0.8 in the LAD
- •Coronary spasm
- •Left ventricular ejection fraction <0.50 or a history of anterior MI in patients in the control group
- •Hypertrophic cardiomyopathy
- •Severe valvular heart disease
- •History of coronary artery bypass graft
- •Patients with limited legal capacity or patients under guardianship/tutorship
- •Patients with anticipated poor compliance as assessed by the investigator
- •Patients not affiliated to any social security regime.
- •Pregnant women.
- •Subjects within the exclusion period of another clinical trial as noted in the national registry of research volunteers
结局指标
主要结局
Coronary flow (mL/min) in the LAD
时间窗: At the end of the angiography procedure
Measurement of coronary flow in mL/min in the left anterior descending artery
次要结局
- Myocardial necrosis(Cardiac MRI to be performed 7 to 30 days after index angiography procedure)
- Microvascular resistance(At the end of the angiography procedure)