Myocardial Fibrosis, Function and Aging

NCT ID: NCT03064503

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2024-06-20

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

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

MRI

Intervention Type DEVICE

MRI will be performed to measure interstitial fibrosis

Skin auto-fluorescence

Intervention Type BIOLOGICAL

Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation

Interventions

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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

Intervention Type BIOLOGICAL

MRI

MRI will be performed to measure interstitial fibrosis

Intervention Type DEVICE

Skin auto-fluorescence

Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre CROISILLE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Département de Radiologie, CHU Saint-Etienne - Hôpital Nord

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre CROISILLE, MD, PhD

Role: CONTACT

+33 477 127 584

Facility Contacts

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Pierre CROISILLE, MD, PhD

Role: primary

+33 477 127 584

Other Identifiers

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69HCL15_0744

Identifier Type: -

Identifier Source: org_study_id

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