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Completed

NCT Number: NCT04791852

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

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.

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Key information

Conditions

Cardiac Allograft Vasculopathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donor-derived Cell Free DNA

Diagnostic Test

We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification

Primary outcomes

  1. Correlation between ddcf-DNA and CAV

    Time frame: 2 years

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

  2. Performance of the biomarker for the diagnosis of CAV

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Acronym: FreeDNA-CAV

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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