Evaluation of Coronary Microvascular Dysfunction (EVACORY) (EVACORY)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: a new non-invasive imaging technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isère
    • Grenoble, Isère, France, 38700
      • University hospital of Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a new non-invasive imaging technique; a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease	Procedure: a new non-invasive imaging technique; a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coronary microcirculation	IMR was measured with commercially available software (St Jude Medical Systems) and thermodilution technique on a non-ischemic artery SPECT. Injections of 3 mL of room-temperature saline were made down the coronary artery, and the resting mean transit time (Tmn) was measured. CFR was calculated as resting Tmn divided by hyperemic Tmn. FFR was calculated by the ratio of Pd/Pa at maximal hyperemia.IMR was defined as distal coronary pressure multiplied by the hyperemic mean transit time (mm Hg • seconds, or units [U]). Myocardial Heterogeneity Index (Hi) was measured by an automated analysis developed in our research unit. Hi was finally calculated from images SPECT using a Markovian analysis. For this study Hi is given by the equation: Hi = Σm [1/(1+m)2]Pd(m).	day 0 (inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scintigraphy	An FFR value of 0.80 or less identifies ischemia-causing coronary stenoses. The global summed stress score (SSS) was calculated by adding the scores of the 17 segments in the stress and rest images, respectively. Scans were considered as normal when SSS was < 4.	day 0 (inclusion)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: BARONE ROCHETTE MD Gilles, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2013
• Primary Completion (Actual): December 10, 2016
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; Coronary Microvascular Dysfunction; index of myocardial resistance
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2012-A00986-37