Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single photon emission computed tomography myocardial perfusion imaging
novel cadmium-zinc-telluride (CZT) SPECT cameras
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EARLY POST-STRESS EF CHANGE
Arm Description
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.
Outcomes
Primary Outcome Measures
ischemia by SPECT
severity of inducible / reversible perfusion abnormalities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863952
Brief Title
Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Official Title
Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EARLY POST-STRESS EF CHANGE
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Single photon emission computed tomography myocardial perfusion imaging
Intervention Type
Device
Intervention Name(s)
novel cadmium-zinc-telluride (CZT) SPECT cameras
Primary Outcome Measure Information:
Title
ischemia by SPECT
Description
severity of inducible / reversible perfusion abnormalities
Time Frame
15-30 minutes post stress
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yafim Brodov, MD
Phone
+972526667119
Email
yafim.brodov@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
We'll reach out to this number within 24 hrs