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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05756088
Other study ID # 2000034497
Secondary ID YSI-004
Status Suspended
Phase
First received
Last updated
Start date November 2024
Est. completion date September 2027

Study information

Verified date May 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood draw to measure the levels of dd-cf DNA
Blood draw to measure the levels of dd-cf DNA.

Locations

Country Name City State
United States Yale New Haven Health New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University Natera, Inc., Yale Cardiovascular Research Group

Country where clinical trial is conducted

United States, 

Outcome

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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