Clinical trial NCT02773043: Evaluation of Myocardial Perfusion Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The proposed study is to validate a non-invasive imaging technique to evaluate the myocardial perfusion reserve in comparison with a validated invasive technique, the measure of coronary flow reserve (CRF) with thermodilution.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: an average of 1 year
Secondary outcomes:
measure: Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution.
timeFrame: an average of 1 year
measure: Evaluation of the myocardial perfusion reserve in scintigraphy by the same operator over different time scales and by two different operators.
timeFrame: an average of 1 year
measure: Study the correlations between the level of soluble VE-cadherin (sVE) and the other indicators of coronary endothelial involvement (CRF and RMP).
timeFrame: Day of coronarography
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Michallon
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles BARONE-ROCHETTE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: