search
Back to results

Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers

Primary Purpose

Myocardial Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RMI
myocardial biopsy
blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients who require surgical aortic valve replacement , which will benefit from an MRI to measure fibrosis in the months preceding the surgery.
  • Patient submitted to the social security scheme
  • Patient agreeing to participate in the study and who signed the informed consent.

Exclusion Criteria:

  • A history of myocardial
  • Unstable Patients requiring treatment with catecholamines.
  • hepatocellular insufficiency of alcoholic origin
  • Severe renal impairment
  • Appearance before examining coronary syndrome at high risk, defined according to international recommendations.
  • History of known allergy to gadolinium at diagnosis
  • Pregnant or lactating
  • Patient < 18 years

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myocardial fibrosis

Arm Description

Outcomes

Primary Outcome Measures

quantification of myocardial fibrosis by RMI

Secondary Outcome Measures

measuring biomarkers of fibrosis
BLOOD SAMPLE

Full Information

First Posted
July 5, 2016
Last Updated
November 9, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT02834104
Brief Title
Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers
Official Title
Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2014 (Actual)
Primary Completion Date
December 19, 2015 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present clinically with symptoms of cardiac failure although this is often a subclinical disease. Various imaging modalities and collagen biomarkers have been used as surrogate markers to assess the presence, extent, and turnover of myocardial fibrosis. Techniques using echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to detect early features of systolic and diastolic left ventricular dysfunction and impaired contractile reserve. Further identification of diffuse reactive fibrosis may be possible with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against histology as standard of reference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Fibrosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myocardial fibrosis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RMI
Intervention Type
Other
Intervention Name(s)
myocardial biopsy
Intervention Type
Biological
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
quantification of myocardial fibrosis by RMI
Time Frame
5years
Secondary Outcome Measure Information:
Title
measuring biomarkers of fibrosis
Description
BLOOD SAMPLE
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who require surgical aortic valve replacement , which will benefit from an MRI to measure fibrosis in the months preceding the surgery. Patient submitted to the social security scheme Patient agreeing to participate in the study and who signed the informed consent. Exclusion Criteria: A history of myocardial Unstable Patients requiring treatment with catecholamines. hepatocellular insufficiency of alcoholic origin Severe renal impairment Appearance before examining coronary syndrome at high risk, defined according to international recommendations. History of known allergy to gadolinium at diagnosis Pregnant or lactating Patient < 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers

We'll reach out to this number within 24 hrs