Myocardial Fibrosis, Function and Aging

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Biological: Blood sampling; Device: MRI; Biological: Skin auto-fluorescence

• Registration Number: NCT03064503
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	MRI	Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed
Healthy volunteers	Blood sampling	Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed
Healthy volunteers	Skin auto-fluorescence	Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed

Primary Outcome Measures

Name	Time	Method
Regional myocardial strain	The day of MRI	Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
Advanced Glycation End-products (AGE) rate	The day of MRI	Skin auto-fluorescence AGE measures
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 amino-terminal propeptide of procollagen type III (PIIINP) rate	The day of MRI	Collagen blood biomarker analysis
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate	The day of MRI	Collagen blood biomarker analysis

Trial Locations

Locations (1)

Département de Radiologie, CHU Saint-Etienne - Hôpital Nord; 🇫🇷 Saint Etienne, France