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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CZT SPECT camera Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : December 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019
Arms and Interventions
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Arm Intervention/treatment
non invasive imaging technique Device: CZT SPECT camera


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773043


Locations
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France
CHU Michallon
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Gilles BARONE-ROCHETTE, MD, PhD University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02773043    
Other Study ID Numbers: 38RC14.214
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: October 2017
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases