Acute Heart Graft Rejection Screening by Cardiac Magnetic... | NCT02400840

Studies
Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

NCT02400840

Sponsor

University Hospital, Rouen

Status

Withdrawn

Last Update Posted

May 26, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cardiac Graft

Interventions

cardiac MRI
gadobenic acid intravenous injection 0.2 ml/kg

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study is not feasable yet, due to evolution in the patients' care

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Mar 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2016

Last Update Posted Date

May 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

Detailed Description

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. It can lead to multiple cardiac injuries and sometimes to patient's death. Currently, acute heart graft rejection screening is based on invasive strategies. Gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. Cardiac MRI is an imaging tool recently used in cardiology. It is a non-invasive without any X-Ray exposition method well adapted to assess cardiac function and cardiac muscle composition. Cardiac MRI is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. MRI validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart graft rejection	Experimental	Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time	Procedure: cardiac MRI Drug: gadobenic acid intravenous injection 0.2 ml/kg
No rejection	Active Comparator	Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time	Procedure: cardiac MRI Drug: gadobenic acid intravenous injection 0.2 ml/kg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac MRI	Procedure	Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time	Heart graft rejection No rejection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Extracellular volume as measured by Cardiac MRI		Day 1
T1 as measured by Cardiac MRI		Day 1
T2 as measured by Cardiac MRI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Orthotopic heart transplantation patients
Endomyocardial biopsies < 72h
Estimated glomerular filtration ratio >30ml/min (calculated by Cockcroft formula for patients age < 65 yo or MDRD for patients age >65 ans)
Patients affiliated to French national health insurance
For pre-menopausal female patients, negative pregnancy test
Patient's consent form signature
Patient with correct French writing and speaking comprehension

Exclusion Criteria:

Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1
Patient in need of renal dialysis
Past history of allergic reaction or side effects after gadolinium infusion
Hemodynamical instability
MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980)
Pregnant or breast feeding woman
Patient participating to another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided