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

NCT02576886 | Completed

• 1 other identifier: 01-15-CARD-001
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

supine; prone; myocardial perfusion imaging; radiation exposure; pre-screening tool

Outcome Measures

Primary Outcomes (1)

• 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.

  day of test

Secondary Outcomes (1)

• 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.

  day of test

Study Arms (1)

Supine/Prone Imaging

EXPERIMENTAL

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.

Device: Gamma Camera; Procedure: Prone Imaging

Interventions

Gamma Camera DEVICE

All images acquired with the General Electric Discovery 530c

Also known as: General Electric Discovery 530c

Supine/Prone Imaging

Prone Imaging PROCEDURE

Supine/Prone Imaging

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences - Hamilton General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Deception

Interventions

Gamma Cameras

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Karen Gulenchyn, MD,FRCPC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

CA (1)