NCT01136135

Brief Summary

To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 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

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4.9 years

First QC Date

February 26, 2010

Last Update Submit

August 31, 2015

Conditions

Heart Transplant Rejection

Keywords

Heart transplant rejectioncardiac MRIdiagnosis

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of cardiac MRI for detecting heart transplant rejection will be calculated. The expected sensitivity and specificity are > 95%.

    24 MONTHS

Study Arms (1)

CARDIAC MRI

Other: CARDIAC MRI

Interventions

CARDIAC MRIOTHER

To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.

CARDIAC MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had undergone cardiac transplants

You may qualify if:

  • all patients who had undergone cardiac transplants are eligible

You may not qualify if:

  • no consent
  • allergy to contrast agent (Gadolinium)
  • severe renal failure (clearance \< 30ml/min/1.73m²)
  • claustrophobia
  • severe arrhythmias
  • absence of medical care insurance
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ou Phalla, MCU PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2010

First Posted

June 3, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

FR(1)