The DEPICT Prospective Study: Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury as Assessed by Donor Derived Cell Free DNA Post Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan.
研究概览
简要总结
The goal of this research study is to understand if a blood test in people who have had heart transplants can detect and predict the following:
- Blockages in the small blood vessels of the heart.
- Whether small blockages can turn into more severe blockages in the future.
Participants will undergo blood draws once every 3 months in the first year of the study (4 blood draws total, taking 15 minutes each) and their medical records will be reviewed for 3 years after the date they are enrolled in the study.
详细描述
A prospective, single center, assessment of donor derived cell free DNA in subjects who are post-heart transplant to assess correlation with microvascular flow as assessed by myocardial flow reserve (MFR) on positron emission tomography (PET).
Study design: This prospective, single center registry will enroll up to 88 subjects at Yale New Haven Health System (YNHHS). Patients who get PET scans for routine post-transplant surveillance will be included in the study. Up to an anticipated 44 subjects with low MFR and up to an anticipated 44 subjects with normal MFR will have dd-cf DNA drawn every 3 months for a year.
Patient population: A total of 88 adults referred to have an annual PET stress test as part of routine post-transplant surveillance for cardiac allograft vasculopathy and who are at least 3 years from heart transplantation and meet all eligibility criteria will be enrolled.
Diagnostic assessment: All subjects will have quarterly blood draws during the first year of enrollment to assess the levels of dd- cf DNA. All subjects will also undergo standard of care annual PET scans.
Subject follow up: All subjects will have routine follow-up as clinically necessary based on standard of care. Screening and follow-up data collection will occur through the electronic medical record.
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
- •The patient is over 18 years of age.
- •The patient underwent orthotopic heart transplantation and is undergoing routine cardiac allograft vasculopathy (CAV) surveillance with PET.
- •The patient has no evidence of cardiogenic shock.
- •The patient has no evidence of acute rejection.
- •The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
- •Potential subjects will be excluded if any of the following conditions apply:
排除标准
- •Evidence of moderate to large area of ischemia on the PET.
- •Multiorgan transplantation.
- •Life expectancy <1 year due to non-cardiac conditions.
- •Less than 3 years from transplantation.
- •Patient appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease).
结局指标
主要结局
dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan.
时间窗: Baseline up to 1 year
Changes in dd-cf DNA levels in subjects with low MFR compared to normal MFR.
次要结局
- Impact of low MFR on rejection(3 years)
- Impact of low MFR on need for revascularization(3 years)
- Impact of low MFR on admissions for heart failure(3 years)
- Impact of low MFR on retransplantation(3 years)
- Impact of low MFR on left ventricular ejection fraction(Baseline up to 3 years)
- Impact of low MFR on myocardial infarction (MI)(3 years)
- Impact of low MFR on death(3 years)