Evaluation of Coronary Microvascular Dysfunction (EVACORY) (EVACORY)
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ClinicalTrials.gov Identifier: NCT01995955 |
Recruitment Status :
Completed
First Posted : November 27, 2013
Last Update Posted : May 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Procedure: a new non-invasive imaging technique | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | June 24, 2013 |
Actual Primary Completion Date : | December 10, 2016 |
Actual Study Completion Date : | April 2018 |

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
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Procedure: a new non-invasive imaging technique
a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease |
- coronary microcirculation [ Time Frame: day 0 (inclusion) ]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).
- scintigraphy [ Time Frame: day 0 (inclusion) ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995955
France | |
University Hospital of Grenoble | |
Grenoble, Isère, France, 38700 |
Principal Investigator: | BARONE ROCHETTE MD Gilles | University Hospital, Grenoble |
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT01995955 |
Other Study ID Numbers: |
2012-A00986-37 |
First Posted: | November 27, 2013 Key Record Dates |
Last Update Posted: | May 21, 2018 |
Last Verified: | May 2018 |
Coronary Microvascular Dysfunction coronary artery disease index of myocardial resistance |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |