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Evaluation of Myocardial Perfusion Reserve (EVARESERVE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CZT SPECT camera
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Michallon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

non invasive imaging technique

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
April 25, 2016
Last Updated
December 30, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02773043
Brief Title
Evaluation of Myocardial Perfusion Reserve
Acronym
EVARESERVE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non invasive imaging technique
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
CZT SPECT camera
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution.
Description
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.
Time Frame
an average of 1 year
Title
Evaluation of the myocardial perfusion reserve in scintigraphy by the same operator over different time scales and by two different operators.
Description
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.
Time Frame
an average of 1 year
Title
Study the correlations between the level of soluble VE-cadherin (sVE) and the other indicators of coronary endothelial involvement (CRF and RMP).
Description
Blood test for soluble VE-cadherin (sVE), CRF, RMP
Time Frame
Day of coronarography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles BARONE-ROCHETTE, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

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Evaluation of Myocardial Perfusion Reserve

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