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

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ClinicalTrials.gov Identifier: NCT02863939
Recruitment Status : Unknown
Verified August 2016 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Single photon emission computed tomography myocardial perfusion imaging Other: exercise Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
NICAS
There is only one arm - a single cohort. All patients undergoing the nuclear stress test will also have the NICAS evaluation.
Device: Single photon emission computed tomography myocardial perfusion imaging
a novel cadmium-zinc-telluride (CZT) SPECT camera

Other: exercise



Primary Outcome Measures :
  1. Ischemia [ Time Frame: 15-20 minutes after stress test ]
    Inducible and reversible perfusion defects, representing myocardial ischemia

  2. Cardiac Output [ Time Frame: 15-20 minutes after exercise test ]
    Noninvasive evaluation of cardiac output using a novel algorithm based on impedenace



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863939


Contacts
Contact: Ronen Goldkorn, MD 97235302109 ronen.goldkorn@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02863939     History of Changes
Other Study ID Numbers: NICAS 1.0
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases