MARVEL: Myocardial Fibrosis, Function and Aging

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03064503

Collaborator

(none)

100

Enrollment

Location

Arm

70.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Blood sampling Device: MRI Biological: Skin auto-fluorescence	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

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 :

Feb 20, 2017

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département de Radiologie, CHU Saint-Etienne - Hôpital Nord	Saint Etienne		France	42270

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Pierre CROISILLE, MD, PhD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03064503

Other Study ID Numbers:

69HCL15_0744

First Posted:

Feb 27, 2017

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

myocardial fibrosis

cardiac function

ageing

Additional relevant MeSH terms:

Fibrosis

Study Results

No Results Posted as of Feb 28, 2022