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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04791852
Acronym
FreeDNA-CAV
Enrollment
94
Registered
2021-03-10
Start date
2019-01-10
Completion date
2021-04-15
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Allograft Vasculopathy

Keywords

Donor-derived Cell Free DNA, Heart Transplant

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.

Interventions

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

Sponsors

Puerta de Hierro University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between ddcf-DNA and CAV2 yearsCorrelation between ddcf-DNA levels and the presence of any degree of CAV (CAV0 vs CAV1, 2, or 3)
Performance of the biomarker for the diagnosis of CAV2 yearsDetermine the performance of this biomarker in this situation using receiver-operator characteristics analysis.

Secondary

MeasureTime frameDescription
Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)2 yearsCorrelation 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 yearsCorrelation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026