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Myocardial Fibrosis, Function and Aging (MARVEL)

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
MRI
Skin auto-fluorescence
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring myocardial fibrosis, cardiac function, ageing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Département de Radiologie, CHU Saint-Etienne - Hôpital NordRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteers

Arm Description

Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed

Outcomes

Primary Outcome Measures

Regional myocardial strain
Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)

Secondary Outcome Measures

MRI T1 value
This value is an indicator of interstitial fibrosis and extracellular volume
MRI T1 value
Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume
Apparent Diffusion Coefficient (ADC) with MRI
ADC is measured with diffusion weighted imaging
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate
Collagen blood biomarker analysis
Blood amino-terminal propeptide of procollagen type III (PIIINP) rate
Collagen blood biomarker analysis
Advanced Glycation End-products (AGE) rate
Skin auto-fluorescence AGE measures

Full Information

First Posted
February 21, 2017
Last Updated
June 12, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03064503
Brief Title
Myocardial Fibrosis, Function and Aging
Acronym
MARVEL
Official Title
Myocardial Fibrosis and Changes of Myocardial Function Related to Aging
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
myocardial fibrosis, cardiac function, ageing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI will be performed to measure interstitial fibrosis
Intervention Type
Biological
Intervention Name(s)
Skin auto-fluorescence
Intervention Description
Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation
Primary Outcome Measure Information:
Title
Regional myocardial strain
Description
Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)
Time Frame
The day of MRI
Secondary Outcome Measure Information:
Title
MRI T1 value
Description
This value is an indicator of interstitial fibrosis and extracellular volume
Time Frame
The day of MRI, before gadolinium injection
Title
MRI T1 value
Description
Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume
Time Frame
The day of MRI, 15 minutes after gadolinium injection
Title
Apparent Diffusion Coefficient (ADC) with MRI
Description
ADC is measured with diffusion weighted imaging
Time Frame
The day of MRI
Title
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate
Description
Collagen blood biomarker analysis
Time Frame
The day of MRI
Title
Blood amino-terminal propeptide of procollagen type III (PIIINP) rate
Description
Collagen blood biomarker analysis
Time Frame
The day of MRI
Title
Advanced Glycation End-products (AGE) rate
Description
Skin auto-fluorescence AGE measures
Time Frame
The day of MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre CROISILLE, MD, PhD
Phone
+33 477 127 584
Email
croisille@creatis.insa-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Radiologie, CHU Saint-Etienne - Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD, PhD
Phone
+33 477 127 584
Email
croisille@creatis.insa-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD, PhD

12. IPD Sharing Statement

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Myocardial Fibrosis, Function and Aging

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