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Status unknownNCT01295385Updated Apr 22, 2015

Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy

An interventional study of NUCLEAR MAGNETIC RESONANCE IMAGING and NUCLEAR MAGNETIC RESONANCE IMAGING in Diabetic and Cardiomyopathy, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

Read the detailed description

These techniques allow in this context:

  1. to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers. The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.
  2. to estimate the metabolic and structural abnormalities in this population, with particularly:

    • Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31.
    • Structural abnormalities: become integrated into the description of diabetic cardiomyopathy.
02

Conditions studied

  • Diabetic
  • Cardiomyopathy

Keywords

  • type 2 diabetes
  • Cardiovascular diseases
  • coronary syndrome have abnormalities of glucidic metabolism
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 25 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • more than 18 years old
  • patient type 2 diabetes affects taken care more than 5 years to Timone Hospital
  • patient with a diabetic cardiomyopathy
  • informed and consented

Exclusion criteria

Exclusion Criteria:

  • less than 18 years
  • Pregnant woman
  • patient type 1 diabetes affects
  • patient presents a cardiomyopathy mixed (no diabetic)
  • patients presents an arrhythmia ventriculaire or above - ventriculaire
  • Unstable hémodynamique patients
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    healthy volunteers

    Other: NUCLEAR MAGNETIC RESONANCE IMAGING

  • Active comparator
    patients with a diabetic cardiomyopathy

    Other: NUCLEAR MAGNETIC RESONANCE IMAGING

Interventions

  • OtherNUCLEAR MAGNETIC RESONANCE IMAGING

    Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers.

  • OtherNUCLEAR MAGNETIC RESONANCE IMAGING

    Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique and to estimate the metabolic and structural abnormalities in this population.

06

What researchers measure

Primary outcomes

  1. To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers

    The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.

    Time frame: 12 months

Secondary outcomes

  1. To estimate the metabolic and structural abnormalities in this population

    * Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31 which allows to estimate the energy state of the heart by analyzing the phosphorous metabolites with high energy involved in the myocardial energetic metabolism. * Structural abnormalities: evaluation of the fibrosis and the collagenic deposits by T1 mapping and measurement of relaxation T2 as well as the study of the late enhancement of gadolinium. These structural abnormalities become integrated into the description of diabetic cardiomyopathy.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique - Hopitaux de Marseille
    Marseille, 13, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01295385
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Feb 14, 2011
Start date
Feb 2011
Primary completion
Jun 2015 (estimated)
Completion
Jun 2015 (estimated)
Last update
Apr 22, 2015

Study contacts

Jacques Quilici, Doctor
Contact
jacques.quilici@ap-hm.fr
+33491385973
Jacques Quilici, Doctor
principal investigator · APHM

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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