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

NCT ID: NCT02019212

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-10-27

Brief Summary

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

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.

Conditions

Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

MPI Perfusion Imaging

Clinical patients who have undergone myocardial perfusion imaging with 99mTc

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Renee Hessian

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renée Hessian, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Insitute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20130446-01H

Identifier Type: -

Identifier Source: org_study_id