Myocardial Fibrosis, Function and Aging

Healthy Clinical Trial

— MARVEL  

Official title:

Myocardial Fibrosis and Changes of Myocardial Function Related to Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064503
• Other study ID #: 69HCL15_0744
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: June 20, 2024

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: Pierre CROISILLE, MD, PhD
• Phone: +33 477 127 584
• Email: croisille[@]creatis.insa-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Département de Radiologie, CHU Saint-Etienne - Hôpital Nord	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional myocardial strain	Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)	The day of MRI
Secondary	MRI T1 value	This value is an indicator of interstitial fibrosis and extracellular volume	The day of MRI, before gadolinium injection
Secondary	MRI T1 value	Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume	The day of MRI, 15 minutes after gadolinium injection
Secondary	Apparent Diffusion Coefficient (ADC) with MRI	ADC is measured with diffusion weighted imaging	The day of MRI
Secondary	Blood carboxy-terminal propeptide of procollagen type I (PICP) rate	Collagen blood biomarker analysis	The day of MRI
Secondary	Blood amino-terminal propeptide of procollagen type III (PIIINP) rate	Collagen blood biomarker analysis	The day of MRI
Secondary	Advanced Glycation End-products (AGE) rate	Skin auto-fluorescence AGE measures	The day of MRI