Evaluation of Myocardial Perfusion Reserve

Coronary Artery Disease Clinical Trial

— EVARESERVE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773043
• Other study ID #: 38RC14.214
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2019

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• CZT SPECT camera

Locations

Country	Name	City	State
France	CHU Michallon	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	an average of 1 year
Secondary	Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution.	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.	an average of 1 year
Secondary	Evaluation of the myocardial perfusion reserve in scintigraphy by the same operator over different time scales and by two different operators.	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.	an average of 1 year
Secondary	Study the correlations between the level of soluble VE-cadherin (sVE) and the other indicators of coronary endothelial involvement (CRF and RMP).	Blood test for soluble VE-cadherin (sVE), CRF, RMP	Day of coronarography