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Completed

NCT Number: NCT03064503

Myocardial Fibrosis, Function and Aging

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).

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département de Radiologie, CHU Saint-Etienne - Hôpital Nord

Saint-Etienne, 42270, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

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

Device

MRI will be performed to measure interstitial fibrosis

Skin auto-fluorescence

Biological

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

Primary outcomes

  1. Regional myocardial strain

    Time frame: The day of MRI

    Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)

Secondary outcomes

  1. MRI T1 value

    Time frame: The day of MRI, before gadolinium injection

    This value is an indicator of interstitial fibrosis and extracellular volume

  2. MRI T1 value

    Time frame: 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

  3. Apparent Diffusion Coefficient (ADC) with MRI

    Time frame: The day of MRI

    ADC is measured with diffusion weighted imaging

  4. Blood carboxy-terminal propeptide of procollagen type I (PICP) rate

    Time frame: The day of MRI

    Collagen blood biomarker analysis

  5. Blood amino-terminal propeptide of procollagen type III (PIIINP) rate

    Time frame: The day of MRI

    Collagen blood biomarker analysis

  6. Advanced Glycation End-products (AGE) rate

    Time frame: The day of MRI

    Skin auto-fluorescence AGE measures

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Myocardial Fibrosis and Changes of Myocardial Function Related to Aging

Acronym: MARVEL

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2017
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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