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

NCT02834104 | Completed

• 2 other identifiers: 2011-302011-A01395-36
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Fibrosis

Outcome Measures

Primary Outcomes (1)

• quantification of myocardial fibrosis by RMI

  5years

Secondary Outcomes (1)

• measuring biomarkers of fibrosis

  5 years

Study Arms (1)

Myocardial fibrosis

EXPERIMENTAL

Device: RMI; Other: myocardial biopsy; Biological: blood sample

Interventions

RMI DEVICE

Myocardial fibrosis

myocardial biopsy OTHER

Myocardial fibrosis

blood sample BIOLOGICAL

Myocardial fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• catherine GEINDRE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 15, 2016
• Study Start: November 18, 2014
• Primary Completion: December 19, 2015
• Study Completion: October 27, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

FR (1)