Myocardial Fibrosis, Function and Aging

Study Overview
=================
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).

Official Title
-----------------
Myocardial Fibrosis and Changes of Myocardial Function Related to Aging

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Blood sampling
* Device: MRI
* Biological: Skin auto-fluorescence


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed | Biological: Blood sampling<br>* 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<br>Device: MRI<br>* MRI will be performed to measure interstitial fibrosis<br>Biological: Skin auto-fluorescence<br>* Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional myocardial strain | Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI) | The day of MRI | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial fibrosis, cardiac function, ageing