Viewing Study NCT02863952



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Last Modification Date: 2024-10-26 @ 12:07 PM
Study NCT ID: NCT02863952
Status: UNKNOWN
Last Update Posted: 2016-08-11
First Post: 2016-07-24

Brief Title: Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated StressRest Tc-99m CZT-SPECT MPI
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated StressRest Tc-99m CZT-SPECT MPI
Status: UNKNOWN
Status Verified Date: 2016-08
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None