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

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Myocardial perfusion imaging
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Louis University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging at 10-minute vs. 30-45-minutes

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerability of early imaging at 10 minutes (W10)
The tolerability of W10 will be assessed using 3-point scale Questionnaires.

Full Information

First Posted
August 14, 2012
Last Updated
March 4, 2014
Sponsor
St. Louis University
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01700972
Brief Title
Feasibility and Diagnostic Accuracy of Myocardial Perfusion Imaging Using Early Imaging Protocol
Official Title
Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
The study did not recruit/no study activity occurred.
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Louis University
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging at 10-minute vs. 30-45-minutes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Myocardial perfusion imaging
Other Intervention Name(s)
Myocardial perfusion SPECT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Tolerability of early imaging at 10 minutes (W10)
Description
The tolerability of W10 will be assessed using 3-point scale Questionnaires.
Time Frame
Two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nghi Nguyen, MD, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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