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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Other: Single photon emission computed tomography myocardial perfusion imaging; Device: novel cadmium-zinc-telluride (CZT) SPECT cameras

• Registration Number: NCT02863952
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2016-07-24
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-11
• Study Start: 2016-09
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EARLY POST-STRESS EF CHANGE	novel cadmium-zinc-telluride (CZT) SPECT cameras	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.
EARLY POST-STRESS EF CHANGE	Single photon emission computed tomography myocardial perfusion imaging	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.

Primary Outcome Measures

Name	Time	Method
ischemia by SPECT	15-30 minutes post stress	severity of inducible / reversible perfusion abnormalities