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CompletedNCT02316054EVADIABUpdated Dec 7, 2016

Evaluation of Myocardial Perfusion Heterogeneity Imaging in Diabetes Patients (EVADIAB)

An observational study in Type 2 Diabetes, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years and older
Sex
All
01

Study summary

Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT over clinical and ischemia in high-risk diabetic patients

Read the detailed description

Currently, type II diabetes mellitus (DM), has reached epidemic levels in the world. Risk stratification is paramount in patients with DM due to not all patients with DM have a similar cardiovascular (CV) risk. Imaging has thus taken a central role in the assessment of CV health and in the diagnosis, evaluation, and management of CV diseases in DM. The prognostic value of relative myocardial perfusion imaging (MPI) using single-photon emission tomography (SPECT) is well established. Consistent with this data, DM patients with abnormal relative MPI results also have higher rates of death and non-fatal MI than those with normal results. However, DM patients with normal stress tests also have higher rates of cardiac events than non-DM counterparts with normal tests and despite that most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, real benefit of this strategy has not been demonstrated compared with optimal medical treatment without ischemia detection. New more sensitive noninvasive imaging to assess MPI abnormalities is needed.

Coronary microvascular dysfunction (CMVD) is closely associated with coronary artery disease; it is an independent risk factor and predicts future coronary events or clinically manifest disease up to 10 years later. To date, non-invasive measurement of CMVD myocardial perfusion heterogeneity imaging (MPHI) by SPECT is not available into clinical practice. We developed a new method to study the CMVD by SPECT. In this study, we use a mathematic technique from entropy analysis to provide precise, objective, automated quantification of MPHI at stress and at rest with SPECT. We sought to assess the prognostic value of MPHI in high-risk diabetic patients being investigated for ischemia. Therefore, we prospectively evaluated the incremental prognostic value of MPHI in patients with type 2 DM during long-term follow-up. Coronary microvascular dysfunction is closely associated with coronary artery disease; it is an independent risk factor and predicts future coronary events or clinically manifest disease up to 10 years later.

In this study, we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.

The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 5-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD in diabetes patients with very high risk cardiovascular.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • type 2 diabetes mellitus
  • coronary microvascular disease
  • coronary artery disease
  • myocardial perfusion imaging
  • prognosis
  • atherosclerosis
  • myocardial ischemia
  • coronary heart disease
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 170 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

high-risk cardiovascular type 2 diabetic patients

Inclusion criteria

  • Type 2 diabetes mellitus
  • Clinical indication for myocardial perfusion imaging
  • Diabetics with very high risk of cardiovascular events defined by the SCORE risk

Exclusion criteria

Exclusion Criteria:

  • Pregnant woman
  • Breast feeding women
  • Severe comorbidity with life expectancy 6 months
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No

Groups and cohorts

  • diabetes and MPHI

    myocardial perfusion heterogeneity imaging

    Device: MPHI

Interventions

  • DeviceMPHI

    addictive value of MPHI to management of high risk cardiovascular type 2 diabetes

06

What researchers measure

Primary outcomes

  1. cardiac death,or Q-wave myocardial infarction (MI), or the need for myocardial revascularization > 3 months after SPECT

    Composite outcome: cardiac death, Q-wave myocardial infarction (MI), the need for myocardial revascularization \> 3 months after SPECT

    Time frame: 4 years

Secondary outcomes

  1. cardiac death

    death from coronary artery disease, heart failure or sudden death

    Time frame: 4 years

  2. non fatal myocardial infarction

    non fatal myocardial infarction

    Time frame: 4 years

  3. myocardial revascularization > 3 months after SPECT

    myocardial revascularization \> 3 months after SPECT

    Time frame: 2 years

07

Study locations

1 site
  • university Hospital
    Grenoble, 38000, France
08

References and documents

Publications

  • Djaileb L, Seiller A, Canu M, De Leiris N, Martin A, Poujol J, Fraguas-Rubio A, Leenhardt J, Carabelli A, Calizzano A, De Fondaumiere M, Broisat A, Desvignes M, Vanzetto G, Ghezzi C, Fagret D, Riou LM, Barone-Rochette G. Prognostic value of SPECT myocardial perfusion entropy in high-risk type 2 diabetic patients. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1813-1821. doi: 10.1007/s00259-020-05110-4. Epub 2020 Nov 20. PubMed 33219463 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02316054
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Dec 12, 2014
Start date
Nov 2007
Primary completion
May 2015
Completion
May 2015
Last update
Dec 7, 2016

Study contacts

Gilles Barone-Rochette, MD,PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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