NCT02773043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 26, 2025

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

April 25, 2016

Last Update Submit

December 18, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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

    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.

    an average of 1 year

Secondary Outcomes (3)

  • Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution.

    an average of 1 year

  • 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

  • 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

Study Arms (1)

non invasive imaging technique

OTHER
Device: CZT SPECT camera

Interventions

CZT SPECT cameraDEVICE
non invasive imaging technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myocardial scintigraphy with pharmacologic stress and abnormal results
  • Coronarography indicated
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Michallon

La Tronche, 38700, France

Location

Related Publications (1)

  • Djaileb L, De Leiris N, Canu M, Sy OP, Seiller A, Leenhardt J, Charlon C, Faure M, Caillard J, Broisat A, Borel AL, Lablanche S, Betry C, Ghezzi C, Vanzetto G, Fagret D, Riou LM, Barone-Rochette G. Regional CZT myocardial perfusion reserve for the detection of territories with simultaneously impaired CFR and IMR in patients without obstructive coronary artery disease: a pilot study. J Nucl Cardiol. 2023 Aug;30(4):1656-1667. doi: 10.1007/s12350-023-03206-6. Epub 2023 Feb 22.

    PMID: 36813934RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Gilles BARONE-ROCHETTE, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 16, 2016

Study Start

December 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

December 26, 2025

Record last verified: 2017-10

Locations

FR(1)