Prognostic Value of Stress SPECT Myocardial Perfusion Imaging With Half Dose 99mTc-Tetrofosmin

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Completed
CT.gov ID
NCT02019212
Collaborator
(none)
4,000
1
40.9
97.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the quality and prognostic ability of low dose 99mTc-tetrofosmin Myocardial Perfusion SPECT Imaging.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of this study is to determine if myocardial perfusion imaging (MPI) using a new SPECT reconstruction software and a low dose (LD) of 99mTC-tetrofosmin will provide equal quality and prognostic value as a full dose (FD) of 99mTc-tetrofosmin myocardial perfusion SPECT imaging methodology.

    The images of clinical patients from the Diagnostic Imaging Department will be assessed and compared for image quality and myocardial perfusion. The outcomes of participants that have had FD studies will be compared to those who have had LD studies. Consented participants will be contacted and will be asked to provide information on their cardiovascular health since the date of their LD or FD scan, such as non fatal myocardial infarction, death, congestive heart failure, admission to hospital with chest pain, further cardiac diagnostic testing, including angiography and early and late revascularization. The event information will be tabulated at 6, 12, 18, and 24 months for the LD and FD studies.

    The study hypothesizes that there will be no difference in the quality and prognostic value between the LD and FD 99mTc-tetrofosmin SPECT MPI imaging protocols. The study hypothesizes that there will be no increase in repeat diagnostic testing and angiography with using the LD imaging protocol.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Prognostic Value of Stress SPECT Myocardial Perfusion Imaging With Half Dose 99mTc-tetrofosmin
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Oct 27, 2016
    Actual Study Completion Date :
    Oct 27, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    MPI Perfusion Imaging

    Clinical patients who have undergone myocardial perfusion imaging with 99mTc

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular Outcomes [15 minutes]

      The primary objective is to compare the cardiovascular outcomes of participants that have had FD studies to those that have had LD studies. These cardiovascular outcomes include myocardial infarction, death, congestive heart failure, hospitalization with chest pain, further diagnostic testing, including angioplasty, and early and late revascularization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants who have completed the FD and LD MPI studies on the GE Infinia Haweye or GE NM 530 (CZT crystal) cameras

    • Retrospective participants must consent to the study interview(s) for data collection

    • Prospective participants must consent to follow up for data collection

    Exclusion Criteria:
    • Unwilling to consent to data collection either retrospectively or in follow up prospectively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Ottawa Heart Insitute Ottawa Ontario Canada K1Y 4W7

    Sponsors and Collaborators

    • Ottawa Heart Institute Research Corporation

    Investigators

    • Principal Investigator: RenĂ©e Hessian, MD, Ottawa Heart Institute Research Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renee Hessian, MD, Ottawa Heart Institute Research Corporation
    ClinicalTrials.gov Identifier:
    NCT02019212
    Other Study ID Numbers:
    • 20130446-01H
    First Posted:
    Dec 24, 2013
    Last Update Posted:
    Apr 13, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Renee Hessian, MD, Ottawa Heart Institute Research Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 13, 2017