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Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results (SFSO-MPI)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gamma Camera
Prone Imaging
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring supine, prone, myocardial perfusion imaging, radiation exposure, pre-screening tool

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any patient referred for a clinically indicated rest/stress myocardial perfusion imaging test

Exclusion Criteria:

  • None

Sites / Locations

  • Hamilton Health Sciences - Hamilton General Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supine/Prone Imaging

Arm Description

The patient will be imaged in the standard supine position and then an additional image will be acquired of the patient in the prone position.

Outcomes

Primary Outcome Measures

Performance of the screening tool for each imaging protocol will be evaluated in terms of sensitivity and specificity to predict an unsuccessful SFSO study.
The performance of the screening tool with supine-only and combined supine-prone imaging will be compared with a McNemar Chi-squared test for each of Group 1 and Group 2 to determine if the combined imaging protocol reduces equivocal results.

Secondary Outcome Measures

Negative predictive value (i.e. the likelihood of successfully predicting a normal MPI based on the screening tool and a normal stress test) will be calculated for each of Group 1 and Group 2 with supine, and supine/prone imaging.
The results for each group will be compared using a paired t-test, while results across groups will be compared using an unpaired t-test.

Full Information

First Posted
October 13, 2015
Last Updated
January 14, 2016
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02576886
Brief Title
Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results
Acronym
SFSO-MPI
Official Title
Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results in Patients Undergoing Testing in a Tertiary Care Facility
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants are being asked to participate in this research study because the participant's doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography) scan to look at the blood flow in the participants heart. Myocardial perfusion imaging is a proven test that looks at the blood flow to the participant's heart after the injection of a radioactive tracer. The standard test requires two injections of the radioactive tracer and takes images of the participant's heart at rest and after a stress test. It has been proposed that in some cases, patients could have images done only after the stress portion of the test and, if normal, the rest images would not need to be done. In this case, only one injection of the radioactive tracer would be needed. It has further been proposed that adding another stress image made with the participant lying on their stomach, will increase the confidence of the reporting doctor in reporting stress images. The purpose of this study is to find out if the extra information added from the image with the participant on their stomach helps the doctor when reporting the test results.
Detailed Description
Successfully implementing a SFSO-MPI protocol requires a validated pre-screening tool and a proven imaging protocol that aids the physician in reporting the study with confidence. The investigator's previous study, entitled "The feasibility of Stress-First/Stress-Only Myocardial Perfusion Imaging to reduce patient radiation exposure in a selected subset of patients undergoing testing in a tertiary care facility (SFSO-MPI)", was designed to validate a pre-screening tool developed by Duvall et al. In the investigator's population the tool demonstrated sensitivity and specificity (95% CI) of 0.79 (0.74-0.83) and 0.55 (0.48-0.62) (unpublished data). The sensitivity was lower than previous published. However the investigators noted that a greater proportion of participants were classified as abnormal (55% vs 31 and 36% in the two cohorts described by Duvall et al) and a high number of patients (15%) were reported as having equivocal stress images. These factors may have affected the sensitivity of the pre-screening tool. A greater proportion of the investigator's participants would then have required a rest study for proper interpretation of the test. Additional imaging increases the patients' radiation exposure and time requirement for the study and affects the proper allocation of department resources. The department routinely images patients in only the supine position. The implementation of routine combined supine/prone imaging is expected to decrease image artifacts which may reduce the number of studies reported as equivocal. If combined supine/prone imaging is successful in changing the interpretation of a significant proportion of equivocal stress studies to normal, then the need for rest imaging will be obviated in a larger group of patients, resulting in reduced radiation dose to patients and medical staff, better laboratory efficiency due to faster throughput, reduced time commitment for patients and lower radiopharmaceutical cost. This change to practice will also further aid meeting the American Society of Nuclear Cardiology (ASNC) goal of no more than 9mSv patient exposure in 50% of studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
supine, prone, myocardial perfusion imaging, radiation exposure, pre-screening tool

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supine/Prone Imaging
Arm Type
Experimental
Arm Description
The patient will be imaged in the standard supine position and then an additional image will be acquired of the patient in the prone position.
Intervention Type
Device
Intervention Name(s)
Gamma Camera
Other Intervention Name(s)
General Electric Discovery 530c
Intervention Description
All images acquired with the General Electric Discovery 530c
Intervention Type
Procedure
Intervention Name(s)
Prone Imaging
Primary Outcome Measure Information:
Title
Performance of the screening tool for each imaging protocol will be evaluated in terms of sensitivity and specificity to predict an unsuccessful SFSO study.
Description
The performance of the screening tool with supine-only and combined supine-prone imaging will be compared with a McNemar Chi-squared test for each of Group 1 and Group 2 to determine if the combined imaging protocol reduces equivocal results.
Time Frame
day of test
Secondary Outcome Measure Information:
Title
Negative predictive value (i.e. the likelihood of successfully predicting a normal MPI based on the screening tool and a normal stress test) will be calculated for each of Group 1 and Group 2 with supine, and supine/prone imaging.
Description
The results for each group will be compared using a paired t-test, while results across groups will be compared using an unpaired t-test.
Time Frame
day of test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any patient referred for a clinically indicated rest/stress myocardial perfusion imaging test Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Gulenchyn, MD,FRCPC
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences - Hamilton General Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

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Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results

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