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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Myocardial Perfusion Reserve
Official Title  ICMJE Not Provided
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: CZT SPECT camera
Study Arms  ICMJE non invasive imaging technique
Intervention: Device: CZT SPECT camera
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
33
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773043
Other Study ID Numbers  ICMJE 38RC14.214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilles BARONE-ROCHETTE, MD, PhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP