Back to resultsEvaluation of Coronary Microvascular Dysfunction (EVACORY) (EVACORY)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
a new non-invasive imaging technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Microvascular Dysfunction, coronary artery disease, index of myocardial resistance
Eligibility Criteria
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
Sites / Locations
- University Hospital of Grenoble
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a new non-invasive imaging technique
Arm Description
a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease
Outcomes
Primary Outcome Measures
coronary microcirculation
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).
Secondary Outcome Measures
scintigraphy
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.
Full Information
NCT ID
NCT01995955
First Posted
November 27, 2012
Last Updated
May 18, 2018
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT01995955
Brief Title
Evaluation of Coronary Microvascular Dysfunction (EVACORY)
Acronym
EVACORY
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 24, 2013 (Actual)
Primary Completion Date
December 10, 2016 (Actual)
Study Completion Date
April 2018 (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 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Microvascular Dysfunction, coronary artery disease, index of myocardial resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a new non-invasive imaging technique
Arm Type
Experimental
Arm Description
a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease
Intervention Type
Procedure
Intervention Name(s)
a new non-invasive imaging technique
Intervention Description
a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease
Primary Outcome Measure Information:
Title
coronary microcirculation
Description
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).
Time Frame
day 0 (inclusion)
Secondary Outcome Measure Information:
Title
scintigraphy
Description
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.
Time Frame
day 0 (inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BARONE ROCHETTE MD Gilles
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38700
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Coronary Microvascular Dysfunction (EVACORY)
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