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Myocardial Fibrosis, Function and Aging (MARVEL)

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ClinicalTrials.gov Identifier: NCT03064503
Recruitment Status : Unknown
Verified February 2017 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : February 27, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as diastolic function is reported to change according to age. The objective is to explore the relationship between myocardial function changes, with local (T1 and diffusion) fibrosis measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin auto-fluorescence and collagen blood-biomarkers).

Condition or disease Intervention/treatment Phase
Healthy Biological: Blood sampling Device: MRI Biological: Skin auto-fluorescence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Myocardial Fibrosis and Changes of Myocardial Function Related to Aging
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Arm Intervention/treatment
Experimental: Healthy volunteers
Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed
Biological: Blood sampling
Blood sampling will be performed at inclusion to investigate some biological eligibility criteria, and the day of MRI in order to analyse fibrosis biomarkers and collagen synthesis biomarkers

Device: MRI
MRI will be performed to measure interstitial fibrosis

Biological: Skin auto-fluorescence
Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation




Primary Outcome Measures :
  1. Regional myocardial strain [ Time Frame: The day of MRI ]
    Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)


Secondary Outcome Measures :
  1. MRI T1 value [ Time Frame: The day of MRI, before gadolinium injection ]
    This value is an indicator of interstitial fibrosis and extracellular volume

  2. MRI T1 value [ Time Frame: The day of MRI, 15 minutes after gadolinium injection ]
    Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume

  3. Apparent Diffusion Coefficient (ADC) with MRI [ Time Frame: The day of MRI ]
    ADC is measured with diffusion weighted imaging

  4. Blood carboxy-terminal propeptide of procollagen type I (PICP) rate [ Time Frame: The day of MRI ]
    Collagen blood biomarker analysis

  5. Blood amino-terminal propeptide of procollagen type III (PIIINP) rate [ Time Frame: The day of MRI ]
    Collagen blood biomarker analysis

  6. Advanced Glycation End-products (AGE) rate [ Time Frame: The day of MRI ]
    Skin auto-fluorescence AGE measures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • physical activity ≤ 3 x(30') per week
  • no history of smoking, diabetes, myocardial infarction, heart failure, hypertension (<140 or <90 mmHg) and no anti-hypertensive or cardiovascular-related medications
  • no familial history of early myocardial ischemia
  • body mass index (BMI) <30kg/m2
  • normal routine lipid blood analysis
  • glycemia <1.26g/l
  • normal electrocardiogram (ECG)

Exclusion Criteria:

  • arrhythmia
  • hepatic insufficiency
  • pregnancy
  • claustrophobia
  • MRI contrast allergy,
  • general contraindications to MRI such as pacemaker, etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064503


Contacts
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Contact: Pierre CROISILLE, MD, PhD +33 477 127 584 croisille@creatis.insa-lyon.fr

Locations
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France
Département de Radiologie, CHU Saint-Etienne - Hôpital Nord Recruiting
Saint Etienne, France, 42270
Contact: Pierre CROISILLE, MD, PhD    +33 477 127 584    croisille@creatis.insa-lyon.fr   
Principal Investigator: Pierre CROISILLE, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre CROISILLE, MD, PhD CHU Saint-Etienne

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03064503     History of Changes
Other Study ID Numbers: 69HCL15_0744
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
myocardial fibrosis
cardiac function
ageing

Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes