Evaluation of Myocardial Perfusion Reserve

NCT ID: NCT02773043

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non invasive imaging technique

Group Type OTHER

CZT SPECT camera

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CZT SPECT camera

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilles BARONE-ROCHETTE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Michallon

La Tronche, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 36813934 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

38RC14.214

Identifier Type: -

Identifier Source: org_study_id