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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Fibrosis
• Intervention / Treatment: Device: RMI; Other: myocardial biopsy; Biological: blood sample

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myocardial fibrosis	Device: RMI; Other: myocardial biopsy; Biological: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quantification of myocardial fibrosis by RMI	5years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring biomarkers of fibrosis	BLOOD SAMPLE	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2014
• Primary Completion (Actual): December 19, 2015
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 2011-30; 2011-A01395-36 (Other Identifier: ansm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided