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OpenTrials
Completed

NCT Number: NCT02834104

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.

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Key information

Conditions

Myocardial Fibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RMI

Device

myocardial biopsy

Other

Blood sample

Biological

Primary outcomes

  1. quantification of myocardial fibrosis by RMI

    Time frame: 5years

Secondary outcomes

  1. measuring biomarkers of fibrosis

    Time frame: 5 years

    BLOOD SAMPLE

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2022
First posted
Jul 15, 2016
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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