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

This study is currently recruiting participants.
Verified February 2013 by St. Louis University
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT01700972
First received: August 14, 2012
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Procedure: Myocardial perfusion imaging
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    The tolerability of W10 will be assessed using 3-point scale Questionnaires.


Estimated Enrollment: 36
Study Start Date: February 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Myocardial perfusion SPECT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700972

Locations
United States, Missouri
Saint Louis University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nghi Nguyen, MD, PhD     314-577-8047     nguyenn@slu.edu    
Contact: Angela Watson     314-268-5784     watsonar@slu.edu    
Principal Investigator: Nghi Nguyen, MD, PhD            
Sub-Investigator: Lisa Alderson, MD            
Sponsors and Collaborators
St. Louis University
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Nghi Nguyen, MD, PhD St. Louis University
  More Information

No publications provided

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT01700972     History of Changes
Other Study ID Numbers: REGA-12B03
Study First Received: August 14, 2012
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013