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

NCT ID: NCT02316054

Last Updated: 2016-12-07

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

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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diabetes and MPHI

myocardial perfusion heterogeneity imaging

MPHI

Intervention Type DEVICE

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

Interventions

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MPHI

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

Intervention Type DEVICE

Eligibility Criteria

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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

* Pregnant woman
* Breast feeding women
* Severe comorbidity with life expectancy 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Barone-Rochette, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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university Hospital

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33219463 (View on PubMed)

Other Identifiers

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2014-02

Identifier Type: -

Identifier Source: org_study_id