Evaluation of Coronary Microvascular Dysfunction (EVACORY)

NCT ID: NCT01995955

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-24
• Study Completion Date: 2018-04-30

Brief Summary

The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

Detailed Description

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.

Index of microcirculatory resistance (IMR) is a validated method to Assessment of the Coronary Microcirculation but this is an invasive technique.

In this study, we use a new mathematic technique from homogeneity analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with new camera CZT SPECT. We compare the results with those of the measurement of IMR.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

a new non-invasive imaging technique

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

Group Type: EXPERIMENTAL

a new non-invasive imaging technique

Intervention Type: PROCEDURE

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

Interventions

a new non-invasive imaging technique

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Stable angina
• Cadmium-zinc-telluride gamma camera SPECT
• Coronarography

Exclusion Criteria

• Pregnant woman
• Patient with terminal illness,
• Terminal Renal failure
• Allergy to iodine
• Contraindications for adenosine: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome, Systolic blood pressure less than 90mm Hg, Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test, Known hypersensitivity to adenosine, Unstable acute myocardial infarction or acute coronary syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BARONE ROCHETTE MD Gilles

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital of Grenoble

Grenoble, Isère, France

Countries

France

Other Identifiers

2012-A00986-37

Identifier Type: -

Identifier Source: org_study_id