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

Completed
Conditions
Cardiac Allograft Vasculopathy
Registration Number
NCT04791852
Lead Sponsor
Puerta de Hierro University Hospital
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Performance of the biomarker for the diagnosis of CAV2 years

Determine the performance of this biomarker in this situation using receiver-operator characteristics analysis.

Correlation between ddcf-DNA and CAV2 years

Correlation between ddcf-DNA levels and the presence of any degree of CAV (CAV0 vs CAV1, 2, or 3)

Secondary Outcome Measures
NameTimeMethod
Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)2 years

Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)

Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)2 years

Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)

Trial Locations

Locations (1)

University Hospital Puerta de Hierro

🇪🇸

Majadahonda, Madrid, Spain

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