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

September 15, 2021 updated by: Javier Segovia Cubero, Puerta de Hierro University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • University Hospital Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart Transplant recipients that undergo routine surveillance coronary angiogram

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 6, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FreeDNA-CAV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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