Endothelial Dysfunction Clinical Trial
— DEPICTOfficial title:
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
Verified date | May 2024 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Suspended |
Enrollment | 88 |
Est. completion date | September 2027 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Potential subjects must meet all of the following criteria to be eligible for inclusion in the study: General Inclusion Criteria: - 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: Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Health | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Natera, Inc., Yale Cardiovascular Research Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan. | Changes in dd-cf DNA levels in subjects with low MFR compared to normal MFR. | Baseline up to 1 year | |
Secondary | Impact of low MFR on rejection | Changes in rates of rejection in participants with low MFR compared with normal MFR. | 3 years | |
Secondary | Impact of low MFR on left ventricular ejection fraction | Changes in left ventricular ejection fraction in participants with low MFR compared with normal MFR. | Baseline up to 3 years | |
Secondary | Impact of low MFR on need for revascularization | Changes in rates of need for revascularization in participants with low MFR compared with normal MFR. | 3 years | |
Secondary | Impact of low MFR on myocardial infarction (MI) | Changes in rates of MI in participants with low MFR compared with normal MFR. | 3 years | |
Secondary | Impact of low MFR on admissions for heart failure | Changes in number of admissions for heart failure in participants with low MFR compared with normal MFR. | 3 years | |
Secondary | Impact of low MFR on retransplantation | Changes in rates of retransplantation in participants with low MFR compared with normal MFR. | 3 years | |
Secondary | Impact of low MFR on death | Changes in rate of death in participants with low MFR compared with normal MFR. | 3 years |
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