EVARESERVE: Evaluation of Myocardial Perfusion Reserve

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02773043
Collaborator
(none)
36
1
1
43
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CZT SPECT camera
N/A

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

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: non invasive imaging technique

Device: CZT SPECT camera

Outcome Measures

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 [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. [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. [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). [Day of coronarography]

    Blood test for soluble VE-cadherin (sVE), CRF, RMP

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU Michallon La Tronche France 38700

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Gilles BARONE-ROCHETTE, MD, PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02773043
Other Study ID Numbers:
  • 38RC14.214
First Posted:
May 16, 2016
Last Update Posted:
Jan 2, 2020
Last Verified:
Oct 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 2, 2020