Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI

NCT ID: NCT02863952

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-08-31

Brief Summary

The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Detailed Description

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (CAD). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of CAD or underestimates its extent. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease has stimulated studies to improve the diagnostic accuracy of SPECT MPI. These studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF), wall motion abnormalities and transient LV dilation. However, these parameters were derived from data acquired using conventional Anger cameras as long as 60 minutes after stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its rapid transient changes. However, with highly sensitive detectors and short lived tracers, the ability of PET MPI to measure EF during peak of stress has been reported. Similarly, the novel cadmium-zinc-telluride (CZT) SPECT cameras with solid state cardiac-focused detectors are significantly more sensitive than the conventional Anger scintillation cameras giving to SPECT the "PET-like" ability to image rapidly right after the stress test. The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EARLY POST-STRESS EF CHANGE

There is only a single arm. All patients undergoing the routine myocardial perfusion SPECT study will also have additional (earlier) image acquisition in order to assess the relation of early wall motion abnormalities to the severity of myocardial ischemia.

Group Type: OTHER

Single photon emission computed tomography myocardial perfusion imaging

Intervention Type: OTHER

novel cadmium-zinc-telluride (CZT) SPECT cameras

Intervention Type: DEVICE

Interventions

Single photon emission computed tomography myocardial perfusion imaging

Intervention Type: OTHER

novel cadmium-zinc-telluride (CZT) SPECT cameras

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• severe aortic stenosis
• resting heart rate > 130 beats/min
• significant atrial or ventricular arrhythmia
• sepsis
• fever
• hemodialysis
• pregnancy

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yafim Brodov, MD

Role: CONTACT

yafim.brodov@sheba.health.gov.il

+972526667119

Other Identifiers

IORG0001472

Identifier Type: -

Identifier Source: org_study_id