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NCT04791852 Clinical Trial

Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Cardiac Allograft Vasculopathy Clinical Trial

— FreeDNA-CAV  

Official title:
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04791852
Other study ID # FreeDNA-CAV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2019
Est. completion date April 15, 2021

Study information
Verified date September 2021
Source Puerta de Hierro University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography > 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date April 15, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients over 18 and under 80 years old, HT > 1 year ago Exclusion Criteria: - Patients under 18 or over 80 years old - Multiorgan transplant - History of acute cellular rejection = 1R or antibody mediated rejection in the previous 6 months - Concomitant infection by CMV

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Donor-derived Cell Free DNA
We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification

Locations
Country Name City State
Spain University Hospital Puerta de Hierro Majadahonda Madrid

Sponsors (1)
Lead Sponsor Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between ddcf-DNA and CAV Correlation between ddcf-DNA levels and the presence of any degree of CAV (CAV0 vs CAV1, 2, or 3) 2 years
Primary Performance of the biomarker for the diagnosis of CAV Determine the performance of this biomarker in this situation using receiver-operator characteristics analysis. 2 years
Secondary Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3) Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3) 2 years
Secondary Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I) Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I) 2 years
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