Feasibility and Diagnostic Accuracy of Myocardial Perfusion Imaging Using Early Imaging Protocol

Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study

The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45 minutes after radiotracer injection, for both rest and stress studies. We hypothesize that early imaging 10 minutes after radiotracer injection provides high image quality and diagnostic accuracy comparable to 30-45 minutes MPI.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Myocardial perfusion imaging

Detailed Description

The current MPI protocol entails imaging within 30-45 minutes after radiotracer injection (W30 imaging), for both the rest and stress part. This delay between the radiotracer injection and imaging is intended to limit the nonspecific liver and gut radioactivity to the heart and allows an optimal imaging of the heart. A recent publication however indicates that an early imaging within 10 minutes after radiotracer injection (W10 imaging) appears feasible and may be as good as W30 imaging.

Encouraged by the recent data, we think that a waiting time of 10 minutes is feasible while preserving the image quality; thus, we would like to assess the feasibility and accuracy of W10 imaging compared with W30 imaging in this study. The main purpose of this study is to obtain imaging information on the use of early imaging (W10). The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard. The tolerability of W10 will be assessed using 3-point scale Questionnaires.

This study will determine if early MPI imaging within 10 minutes works as well as imaging after 30-45 minutes waiting and its role in the diagnosis of coronary artery disease. The major advantages of this new imaging procedure include the shortening of the procedure time, the reduction of patient discomfort and improvement of patient care.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Men and women ≥18 years of age of any race /ethnicity
• Patient has undergone or is being scheduled for a clinically indicated cardiac catheterization with or without angioplasty
• Patient may have suffered myocardial infarction more than 3 days before MPI
• Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to MPI
• Interval between T99m-MPI and cardiac catheterization is within 30 days
• Females are not pregnant and lactating
• Provide signed Informed Consent prior to undergoing the study procedures

Exclusion Criteria:

• Patients less than 18 years of age
• Female patient is pregnant or nursing
• Patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period
• History of 2nd or 3rd degree AV-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
• Myocardial infarction within 3 days before MPI
• Percutaneous transluminal coronary angioplasty (PTCA) or stent placement within 3 days prior to MPI
• Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
• Current history of exacerbated COPD or asthma
• Known hypersensitivity or contraindication to regadenoson or aminophylline
• Use of caffeinated substance, dipyridamole-containing medication, aminophylline, or xanthines containing medication (e.g. theophylline) within the 12 hours prior to Lexiscan administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging at 10-minute vs. 30-45-minutes; The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.	Procedure: Myocardial perfusion imaging; The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.; Other Names: Myocardial perfusion SPECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection	The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of early imaging at 10 minutes (W10)	The tolerability of W10 will be assessed using 3-point scale Questionnaires.	Two hours

Collaborators and Investigators

• Sponsor: St. Louis University
• Collaborators: Astellas Pharma US, Inc.
• Investigators: Principal Investigator: Nghi Nguyen, MD, PhD, St. Louis University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: REGA-12B03