NCT03064503

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6.8 years

First QC Date

February 21, 2017

Last Update Submit

March 11, 2026

Conditions

Healthy

Keywords

myocardial fibrosiscardiac functionageing

Outcome Measures

Primary Outcomes (1)

  • Regional myocardial strain

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

    The day of MRI

Secondary Outcomes (6)

  • MRI T1 value

    The day of MRI, before gadolinium injection

  • MRI T1 value

    The day of MRI, 15 minutes after gadolinium injection

  • Apparent Diffusion Coefficient (ADC) with MRI

    The day of MRI

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

    The day of MRI

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

    The day of MRI

  • +1 more secondary outcomes

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

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

Biological: Blood samplingDevice: MRIBiological: Skin auto-fluorescence

Interventions

Blood samplingBIOLOGICAL

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

Healthy volunteers
MRIDEVICE

MRI will be performed to measure interstitial fibrosis

Healthy volunteers
Skin auto-fluorescenceBIOLOGICAL

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

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Radiologie, CHU Saint-Etienne - Hôpital Nord

Saint-Etienne, 42270, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre CROISILLE, MD, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 27, 2017

Study Start

February 20, 2017

Primary Completion

December 5, 2023

Study Completion

December 5, 2023

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

FR(1)