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Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single photon emission computed tomography myocardial perfusion imaging
novel cadmium-zinc-telluride (CZT) SPECT cameras
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed.

-

Exclusion Criteria:

  • severe aortic stenosis
  • resting heart rate > 130 beats/min
  • significant atrial or ventricular arrhythmia
  • sepsis
  • fever
  • hemodialysis
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    EARLY POST-STRESS EF CHANGE

    Arm Description

    There is only a single arm. All patients undergoing the routine myocardial perfusion SPECT study will also have additional (earlier) image acquisition in order to assess the relation of early wall motion abnormalities to the severity of myocardial ischemia.

    Outcomes

    Primary Outcome Measures

    ischemia by SPECT
    severity of inducible / reversible perfusion abnormalities

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2016
    Last Updated
    August 10, 2016
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02863952
    Brief Title
    Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
    Official Title
    Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
    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
    August 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.
    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). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of CAD or underestimates its extent. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease has stimulated studies to improve the diagnostic accuracy of SPECT MPI. These studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF), wall motion abnormalities and transient LV dilation. However, these parameters were derived from data acquired using conventional Anger cameras as long as 60 minutes after stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its rapid transient changes. However, with highly sensitive detectors and short lived tracers, the ability of PET MPI to measure EF during peak of stress has been reported. Similarly, the novel cadmium-zinc-telluride (CZT) SPECT cameras with solid state cardiac-focused detectors are significantly more sensitive than the conventional Anger scintillation cameras giving to SPECT the "PET-like" ability to image rapidly right after the stress test. The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

    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
    EARLY POST-STRESS EF CHANGE
    Arm Type
    Other
    Arm Description
    There is only a single arm. All patients undergoing the routine myocardial perfusion SPECT study will also have additional (earlier) image acquisition in order to assess the relation of early wall motion abnormalities to the severity of myocardial ischemia.
    Intervention Type
    Other
    Intervention Name(s)
    Single photon emission computed tomography myocardial perfusion imaging
    Intervention Type
    Device
    Intervention Name(s)
    novel cadmium-zinc-telluride (CZT) SPECT cameras
    Primary Outcome Measure Information:
    Title
    ischemia by SPECT
    Description
    severity of inducible / reversible perfusion abnormalities
    Time Frame
    15-30 minutes post stress

    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: the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed. - Exclusion Criteria: severe aortic stenosis resting heart rate > 130 beats/min significant atrial or ventricular arrhythmia sepsis fever hemodialysis pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yafim Brodov, MD
    Phone
    +972526667119
    Email
    yafim.brodov@sheba.health.gov.il

    12. IPD Sharing Statement

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