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

Coronary Artery Disease Clinical Trial

— NICAS  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02863939
• Other study ID #: NICAS 1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2016
• Last updated: August 10, 2016
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: Sheba Medical Center
• Contact: Ronen Goldkorn, MD
• Phone: 97235302109
• Email: ronen.goldkorn[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 79 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Single photon emission computed tomography myocardial perfusion imaging
a novel cadmium-zinc-telluride (CZT) SPECT camera

Other:
• exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia	Inducible and reversible perfusion defects, representing myocardial ischemia	15-20 minutes after stress test	No
Primary	Cardiac Output	Noninvasive evaluation of cardiac output using a novel algorithm based on impedenace	15-20 minutes after exercise test	No