Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 576
- 试验地点
- 6
- 主要终点
- Clinically relevant composite: Death
研究概览
简要总结
Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance.
详细描述
MARINER is a Canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive PET strategy compared to ICA for CAV surveillance. Patients are randomized to annual PET or ICA for CAV surveillance. Non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic CAV associated with myocardial infarction or heart failure. Secondary outcomes include the rate of new or progressive CAV, number of ICA performed, number of ICA and PET procedural related complications, EuroQol-5 Dimension assessed patient health-related quality of life and health care resource use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Post heart transplant 2-10 years.
- •Age ≥18 years.
- •Able to provide informed consent.
排除标准
- •Contraindication to dipyridamole due to severe aortic stenosis.
- •Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
- •Contraindication to dipyridamole due to severe bronchospasm.
- •Unable to undergo coronary angiography due to allergy to iodinated contrast.
- •Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m
- •for non-dialysis patients as determined by local laboratory analysis.
- •Unable to undergo coronary angiography due to unsuitable vascular access.
- •Treated rejection ≤1-month.
- •Unstable angina or MI ≤7 days.
研究组 & 干预措施
Invasive Coronary Angiography
Patients in this arm will undergo annual CAV surveillance with ICA
干预措施: ICA (Diagnostic Test)
Positron Emission Tomography
Patients in this arm will undergo annual CAV surveillance with PET
干预措施: PET (Diagnostic Test)
结局指标
主要结局
Clinically relevant composite: Death
时间窗: From date of randomization up to a minimum of 2 years
Date of death due to any cause
Clinically relevant composite: Retransplant
时间窗: From date of randomization up to a minimum of 2 years
Heart retransplantation for any indication
Clinically relevant composite: Allograft Dysfunction
时间窗: From date of randomization up to a minimum of 2 years
≥25% decrease in left ventricular ejection fraction
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
时间窗: From date of randomization up to a minimum of 2 years
Angiographic evidence of CAV (ISHLT CAV 1-3)
次要结局
- Rate of new or progressive CAV(From date of randomization up to a minimum of 2 years)
- Number of ICA performed(From date of randomization up to a minimum of 2 years)
- Health Resource Utilization(From date of randomization up to a minimum of 2 years)
- Number of procedural related complications (ICA and PET)(From date of randomization up to a minimum of 2 years)
- Patient Health related outcomes(Baseline and 12-monthly up to a minimum of 2 years)