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

NCT ID: NCT02863939

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NICAS

There is only one arm - a single cohort. All patients undergoing the nuclear stress test will also have the NICAS evaluation.

Group Type: OTHER

Single photon emission computed tomography myocardial perfusion imaging

Intervention Type: DEVICE

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

exercise

Intervention Type: OTHER

Interventions

Single photon emission computed tomography myocardial perfusion imaging

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

Intervention Type: DEVICE

exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ronen Goldkorn, MD

Role: CONTACT

ronen.goldkorn@sheba.health.gov.il

97235302109

Other Identifiers

NICAS 1.0

Identifier Type: -

Identifier Source: org_study_id