Determination of Coronary Flow Reserve by Dynamic Myocardial Perfusion Scintigraphy (ERCAD)

Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Standard analysis, based on the reversibility of regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest, has good sensitivity and negative predictive value in the search for myocardial ischemia. However, two major obstacles persist. First, because of the relative nature of the normalization of cardiac activity, this approach may underestimate the extent of the damage, especially when the territory with the most activity is itself pathological. Thus myocardial perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these disadvantages, several indexes have been proposed to improve the diagnostic performance of perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis. Secondly, the review does not provide any guarantee as to the quality and reproducibility of use of the coronal reserve during stress, in particular during submaximal stress tests and pharmacological stress, the latter being easily antagonized by xanthine derivatives contained in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology - to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly consists of a computer post-processing of the myocardial perfusion scintigraphy data and does not therefore require any additional irradiation (the only difference with respect to the old protocols is the start of the images at the time of publication. injection of the radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared to conventional stress / rest perfusion scintigraphy has not been clearly studied, particularly in the multi-truncal patients.

Study Overview

• Status: Terminated
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Other: Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

• Study Contact: Name: Marc JANIER, PU-PH; Phone Number: +33 0472357227; Email: marc.janier@chu-lyon.fr
• Study Contact Backup: Name: Bastien GREGOIRE, PH; Email: gregoire.bastou@wanadoo.fr

Study Locations

• France
  • Bron, France, 69677
    • Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study is conducted in adults with suspected coronary artery disease or coronary heart disease and referred for functional evaluation by perfusion scintigraphy with dynamic acquisition before coronary angiography.

Description

Inclusion Criteria:

• Patients sent to the Nuclear Medicine Department as part of a functional evaluation by dynamic acquisition tomoscintigraphy and who will benefit from coronary angiography in the Louis Pradel Hospital hemodynamics department, depending on the results and the clinical context , outside of an emergency context.
• Patients who received the information and did not object to participate in the study

Exclusion Criteria:

• Patient with a contraindication to pharmacological stress by dipyridamole or regadenoson (acute coronary syndrome, acute pulmonary embolism, hypertension) severe pulmonary artery disease, acute aortic dissection, symptomatic aortic stenosis, hemodynamic instability, acute myocarditis, pericarditis or endocarditis, severe chronic obstructive pulmonary disease, uncompacted type III atrioventricular block, systolic pressure <90 mmHg, Recent ischemic stroke, hypersensitivity or allergy to active ingredients or excipients)
• Patients under 18 years of age
• Patients with atrial fibrillation complete arrhythmia (ACFA)
• Patients with a history of coronary bypass grafting.
• Patients whose clinical condition requires rapid management not allowing to wait for the completion of the exams
• Pregnancy and breast feeding
• Deprivation of civil rights (guardianship, guardianship, safeguard of justice)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with or suspected coronary heart disease	Other: Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT); Evaluation of the improvement of the sensitivity, in tri-truncular patients, provided by the estimation of the coronal reserve by territory, during the realization of a myocardial perfusion tomoscintigraphy on CZT camera dedicated to cardiology (Discovery NM 530 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of significant stenosis in each of the three coronary areas	The gold standard will be provided by coronarography with Fractional Flow Reserve measurement during the angiographic procedure if necessary. Coronary stenosis with Fractional Flow Reserve <0.8 will be retained as positive	two weeks after MPI SPECT

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 69HCL17_0259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No