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

NCT01700972 | Withdrawn Phase 4 DMC

• 1 other identifier: REGA-12B03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability of early imaging at 10 minutes (W10)

  Two hours

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Myocardial perfusion imaging PROCEDURE

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.

Also known as: Myocardial perfusion SPECT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Saint Louis University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Nghi Nguyen, MD, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: October 4, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)