Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
研究概览
简要总结
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
详细描述
PROPHET-FFR is a ambispective observational study enrolling patients that need invasive functional evaluation in the diagnostic workup of coronary artery disease.
Clinical outcomes of patients that undergo functional assessment after PCI will be compared both to patients undergoing PCI without further evaluations and both to patients that will be deferred due to to negative functional evaluation.
Since the observational nature of the study the decision to perform post-PCI physiological assessment will be left to operator's discretion.
In case of post-PCI functional evaluation results that will be deemed as unsatisfactory by the operator further actions can be taken in order to optimize procedural result. The decision on this opportunity as well as the choice of the strategy to adopt are left to operator's discretion.
The primary endpoint of the study is the rate of MACE defined as the composite of spontaneous MI, target vessel failure, cardiac deaths at 24 months. Follow up will be performed by telephone contact and medical records screening at 12, 24 and 36 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •requiring coronary angiography to assess coronary artery disease;
- •having at least one angiographically intermediate coronary stenosis (eg. 40%-80%) on any vessel requiring invasive functional assessment using FFR (and/or any other surrogate index)
- •being able and legally entitled to give informed consent
排除标准
- •history of severe poorly uncontrolled pulmonary disease
- •hemodynamic instability during the diagnostic or therapeutic procedures;
- •known adenosine intolerance
- •need of mechanical circulatory or ventilatory support;
- •stage IV chronic kidney disease.
- •life expectancy <1 year
- •patients gaining indication to surgical revascularization;
- •major procedural complications during percutaneous revascularization (cardiac arrest needing cardiopulmonary resuscitation, major bleeding , large iatrogenic coronary dissection, coronary embolization in a main vessel, suspected stroke) making post-PCI functional evaluation unsafe or impossible.
结局指标
主要结局
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
时间窗: 2 years
次要结局
- Rate of all-cause Death(1 year, 3 years, 5 years)
- Rate of recurrent or persistent angina(1 year, 3 years, 5 years)
- contrast dose(intraprocedural)
- Rate of cardiac hospitalizations(1 year, 3 years, 5 years)
- absolute and relative change in functional indexes measured before and after any step of the study procedure(intraprocedural)
- post-procedural creatinine level(24 hours and 48 hours)
- Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)](1 year, 3 years, 5 years)
- procedural cost(intraprocedural)
- post-procedural troponin level(24 hours and 48 hours)
- Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7(1 year, 3 years, 5 years)
- fluoroscopy time(intraprocedural)
- number of stents implanted and balloon used for optimization(intraprocedural)
研究者
Antonio Maria Leone, MD
Principal Investigator, Head of Chronic Coronary Syndromes Department at Fondazione Policlinico A. Gemelli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS