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Clinical trial

Myocardial Fibrosis and Changes of Myocardial Function Related to Aging

ID
Name
69HCL15_0744
Description
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).
Trial arms
Trial start
2017-02-20
Estimated PCD
2024-06-20
Trial end
2024-06-20
Status
Recruiting
Treatment
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
Arms:
Healthy volunteers
MRI
MRI will be performed to measure interstitial fibrosis
Arms:
Healthy volunteers
Skin auto-fluorescence
Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation
Arms:
Healthy volunteers
Size
100
Primary endpoint
Regional myocardial strain
The day of MRI
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-06-13

1 organization

2 products

1 indication

Organization
Hospices Civils de Lyon
Product
Blood sampling
Indication
Healthy
Product
Skin auto-fluorescence