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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02863952
Enrollment
100
Registered
2016-08-11
Start date
2016-09-30
Completion date
2017-08-31
Last updated
2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEnovel cadmium-zinc-telluride (CZT) SPECT cameras

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ischemia by SPECT15-30 minutes post stressseverity of inducible / reversible perfusion abnormalities

Contacts

Primary ContactYafim Brodov, MD
yafim.brodov@sheba.health.gov.il+972526667119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026