Cardiac Allograft VasculopathyFreeDNA-CAVNCT04791852
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
An observational study of Cardiac Allograft Vasculopathy, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- What is being tested?
- Donor-derived Cell Free DNA
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2019to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Transplant recipients that undergo routine surveillance coronary angiogram
Who may be able to join
- Patients over 18 and under 80 years old, HT > 1 year ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiac Allograft Vasculopathy
- Being tested
- Donor-derived Cell Free DNA
- Keywords
- Donor-derived Cell Free DNA, Heart Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor-derived Cell Free DNADiagnostic test
We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)
Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)
Measured: 2 years
Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)
Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Jan 2019
- Primary completion31 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Segovia Cubero, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791852
- Sponsor's protocol ID
- FreeDNA-CAV
- Acronym
- FreeDNA-CAV
- Status last verified
- Sep 2021
- First submitted
- 6 Mar 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35463750
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
- ClinicalTrials.gov ID
- NCT04791852
- Acronym / sponsor ID
- FreeDNA-CAV / FreeDNA-CAV
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Donor-derived Cell Free DNA, Heart Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Transplant recipients that undergo routine surveillance coronary angiogram
Key inclusion criteria (1 listed)
- Patients over 18 and under 80 years old, HT > 1 year ago
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor-derived Cell Free DNAWe will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification | Diagnostic test | – |
Primary outcome
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)
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 secondary outcomes
Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)
Time frame: 2 years
Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 35463750Jimenez-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.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Allograft Vasculopathy
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
Recruiting
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Cardiac Allograft Vasculopathy
RecruitingPhase 3
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Cardiac Allograft Vasculopathy, Heart Transplant
Active, not recruitingObservational study
Early Post Transplant Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Not yet recruitingObservational study
Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Allograft Vasculopathy, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ddcf-DNA and CAV (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.