Evaluation of Myocardial Perfusion Reserve (EVARESERVE)
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ClinicalTrials.gov Identifier: NCT02773043 |
Recruitment Status :
Completed
First Posted : May 16, 2016
Last Update Posted : January 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Device: CZT SPECT camera | Not Applicable |
Coronary artery disease is a public health problem. The measurement of myocardial perfusion reserve is a prognostic factor supplemental.
Its measure should influence the treatment and the follow up of the patients. The measurement of CRF by by one pressure-temperature sensor-tipped guide wire is a validated technique to evaluate the myocardial perfusion reserve but it is an invasive technique.
In this study, the investigators will compare this method with a non-invasive method: completely automated analysis and quantification of myocardial blood flow from DICOM files corresponding to stress and rest images was developed with a new camera CZT SPECT.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Actual Study Start Date : | December 2015 |
Actual Primary Completion Date : | July 2019 |
Actual Study Completion Date : | July 2019 |
Arm | Intervention/treatment |
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non invasive imaging technique |
Device: CZT SPECT camera |
- Correlation between the measure of the coronary flow reserve with an invasive reference method (thermodilution) and a new non-invasive method in scintigraphy to measure the myocardial perfusion reserve [ Time Frame: an average of 1 year ]
Coronary flow reserve by thermodilution is the ratio between mean transit time of a room temperature 3-ml bolus of saline during rest and maximal hyperemia.
Coronary flow reserve by CZT camera is given by ratio between Mycoardial perfusion during rest and maximal hyperemia. Myocardial perfusion is given by new software.
- Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution. [ Time Frame: an average of 1 year ]Coronary flow reserve by thermodilution is the ratio between mean transit time of a room temperature 3-ml bolus of saline during rest and maximal hyperemia.
- Evaluation of the myocardial perfusion reserve in scintigraphy by the same operator over different time scales and by two different operators. [ Time Frame: an average of 1 year ]Coronary flow reserve by CZT camera is given by ratio between Mycoardial perfusion during rest and maximal hyperemia. Myocardial perfusion is given by new software.
- Study the correlations between the level of soluble VE-cadherin (sVE) and the other indicators of coronary endothelial involvement (CRF and RMP). [ Time Frame: Day of coronarography ]Blood test for soluble VE-cadherin (sVE), CRF, RMP

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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:
- Myocardial scintigraphy with pharmacologic stress and abnormal results
- Coronarography indicated
- Informed consent
Exclusion Criteria:
- Pregnant woman
- Patient with terminal illness
- Terminal renal failure
- Allergy to iodine
- Informed consent impossible
- Patient under legal protection
- History of coronary artery bypass surgery
- Contraindications for adenosine: asthmatic patients, second or third-degree AV block without pacemaker or sick sinus syndrome. Systolic blood pressure less than 90 mmHg. Recent use of dipyramidole or dipyramidole-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): NCT02773043
France | |
CHU Michallon | |
La Tronche, France, 38700 |
Principal Investigator: | Gilles BARONE-ROCHETTE, MD, PhD | University Hospital, Grenoble |
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT02773043 |
Other Study ID Numbers: |
38RC14.214 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | January 2, 2020 |
Last Verified: | October 2017 |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |