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Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02863939
Acronym
NICAS
Enrollment
100
Registered
2016-08-11
Start date
2016-09-30
Completion date
2017-09-30
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 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.

Interventions

a novel cadmium-zinc-telluride (CZT) SPECT camera

OTHERexercise

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Ischemia15-20 minutes after stress testInducible and reversible perfusion defects, representing myocardial ischemia
Cardiac Output15-20 minutes after exercise testNoninvasive evaluation of cardiac output using a novel algorithm based on impedenace

Contacts

Primary ContactRonen Goldkorn, MD
ronen.goldkorn@sheba.health.gov.il97235302109

Outcome results

None listed

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