NCT06795958

Brief Summary

Acute cardiac rejection is currently diagnosed by endomyocardial biopsy (EMB), but multiparametric cardiac magnetic resonance (CMR) may be a non-invasive alternative by its capacity for myocardial structure and function characterization. Our primary aim was to determine the utility of multiparametric CMR in identifying acute graft rejection in paediatric heart transplant recipients. The second aim was to compare textural features of parametric maps in cases of rejection versus those without rejection.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
45mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Dec 2023Dec 2029

Study Start

First participant enrolled

December 12, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 28, 2025

Status Verified

December 1, 2024

Enrollment Period

5.6 years

First QC Date

December 30, 2024

Last Update Submit

January 26, 2025

Conditions

Pediatric Heart Transplant

Keywords

acute cardiac rejectionpaediatric heart transplantendomyocardial biopsymultiparametric cardiacmagnetic resonance

Outcome Measures

Primary Outcomes (1)

  • To determine the utility of multiparametric CMR in identifying acute graft rejection in paediatric heart transplant recipients

    CMR data were stratified according to the presence (grade ≥ 2) or absence (grade 0 or 1) of significant acute cellular rejection on EMB

    1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children and young adults (transplanted when they were ≤ 18 years)

You may qualify if:

  • children and young adults (transplanted when they were ≤ 18 years) who undergo an EMB for routine surveillance without contraindications to contrast-enhanced CMR

You may not qualify if:

  • We also don't recruit recipients who were \< 3 months post-heart transplantation to reduce the possibility of confounding from ischemia-reperfusion injury that occurs with the heart transplant procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

  • Valentina Gesuete, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Gesuete, MD

CONTACT

0390512149096valentina.gesuete@aosp.bo.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 28, 2025

Study Start

December 12, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 28, 2025

Record last verified: 2024-12

Locations

IT(1)