Back to resultsQuantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI (NICAS)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single photon emission computed tomography myocardial perfusion imaging
exercise
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patients referred to the Nuclear Cardiology Center for a clinically indicated exercise stress MPI study
Exclusion Criteria:
- known standard contraindications for ergometry
- anemia
- hyperthyroidism
- intra- and extra-cardiac shunts
- significant arrhythmia
- hemodialysis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NICAS
Arm Description
There is only one arm - a single cohort. All patients undergoing the nuclear stress test will also have the NICAS evaluation.
Outcomes
Primary Outcome Measures
Ischemia
Inducible and reversible perfusion defects, representing myocardial ischemia
Cardiac Output
Noninvasive evaluation of cardiac output using a novel algorithm based on impedenace
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863939
Brief Title
Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Acronym
NICAS
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
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to test for an early post-stress cardiac output (CO) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.
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) (1). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of or underestimates the extent of CAD. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease (2) has stimulated studies to improve the diagnostic accuracy of SPECT MPI. Such studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF) (3, 4), wall motion abnormalities (5) and transient LV dilation (6) with images acquired on conventional Anger cameras as long as 60 minutes after the stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its transient nature. However, detection of an early post-stress decrease in cardiac output (CO) may serve as a potential marker for the presence of significant or extensive ischemia. The aim of this study is to test for an early post-stress CO change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.
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
NICAS
Arm Type
Other
Arm Description
There is only one arm - a single cohort. All patients undergoing the nuclear stress test will also have the NICAS evaluation.
Intervention Type
Device
Intervention Name(s)
Single photon emission computed tomography myocardial perfusion imaging
Intervention Description
a novel cadmium-zinc-telluride (CZT) SPECT camera
Intervention Type
Other
Intervention Name(s)
exercise
Primary Outcome Measure Information:
Title
Ischemia
Description
Inducible and reversible perfusion defects, representing myocardial ischemia
Time Frame
15-20 minutes after stress test
Title
Cardiac Output
Description
Noninvasive evaluation of cardiac output using a novel algorithm based on impedenace
Time Frame
15-20 minutes after exercise test
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:
Patients referred to the Nuclear Cardiology Center for a clinically indicated exercise stress MPI study
Exclusion Criteria:
known standard contraindications for ergometry
anemia
hyperthyroidism
intra- and extra-cardiac shunts
significant arrhythmia
hemodialysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronen Goldkorn, MD
Phone
97235302109
Email
ronen.goldkorn@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
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