NCT04791852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

March 6, 2021

Last Update Submit

September 15, 2021

Conditions

Cardiac Allograft Vasculopathy

Keywords

Donor-derived Cell Free DNAHeart Transplant

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • 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)

    2 years

Interventions

Donor-derived Cell Free DNADIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart Transplant recipients that undergo routine surveillance coronary angiogram

You may qualify if:

  • Patients over 18 and under 80 years old, HT \> 1 year ago

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (1)

  • Jimenez-Blanco Bravo M, Perez-Gomez L, Hernandez-Perez FJ, Arellano-Serrano C, Torres-Sanabria M, Gomez-Bueno M, Oteo-Dominguez JF, Mingo-Santos S, Segovia-Cubero J. Lack of Usefulness of Donor-Derived Cell-Free DNA as a Biomarker for Cardiac Allograft Vasculopathy: A Prospective Study. Front Cardiovasc Med. 2022 Apr 6;9:856600. doi: 10.3389/fcvm.2022.856600. eCollection 2022.

    PMID: 35463750DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Department

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 10, 2021

Study Start

January 10, 2019

Primary Completion

January 31, 2021

Study Completion

April 15, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

ES(1)