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

Not Applicable

Completed

• Conditions: Myocardial Fibrosis
• Interventions: Device: RMI; Other: myocardial biopsy; Biological: blood sample

• Registration Number: NCT02834104
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-18
• Primary Completion: 2015-12-19
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Study Completion: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocardial fibrosis	blood sample	-
Myocardial fibrosis	RMI	-
Myocardial fibrosis	myocardial biopsy	-

Primary Outcome Measures

Name	Time	Method
quantification of myocardial fibrosis by RMI	5years

Secondary Outcome Measures

Name	Time	Method
measuring biomarkers of fibrosis	5 years	BLOOD SAMPLE

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France