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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Insitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical patients who have undergone myocardial perfusion imaging.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MPI Perfusion Imaging; Clinical patients who have undergone myocardial perfusion imaging with 99mTc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Outcomes	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.	15 minutes

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Renée Hessian, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 27, 2016
• Study Completion (Actual): October 27, 2016

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: radiation; SPECT; myocardial perfusion imaging; 99mTc-tetrofosmin
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 20130446-01H