Half-Dose Radiopharmaceutical in Wide Beam Reconstruction

NCT01499654 | Terminated Results

• 1 other identifier: STU53243
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study is recruiting patients already scheduled for a single photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging technique that uses a radioactive substance, or radiotracer, and special equipment to create three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make the structures of the heart visible and is routinely used to view blood flow in the heart, scan for damaged heart tissue, or assess heart function. For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the test, followed by taking resting images of the heart. For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Participants will receive the same amount of radioactive material that would normally be given for this test; however, it will be administered in two half-doses. Participation in this study will add about 30 minutes to the time it takes to complete the routine test. The investigators expect to enroll about 160 subjects in this study at Northwestern.

Conditions

Myocardial Infarction; Ischemic Heart Disease

Keywords

SPECT MPI; Tomography, Emission-Computed, Single-Photon; Wide Beam Reconstruction

Outcome Measures

Primary Outcomes (2)

• Sum Rest Score

  Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.

  Baseline

• Segments With Resting Perfusion Defect

  Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.

  Baseline

Secondary Outcomes (2)

• Image Quality Score

  Baseline

• Diagnostic Confidence Score

  Baseline

Study Arms (1)

Half-dose radiotracer administration

EXPERIMENTAL

For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses.

Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

Interventions

Half-dose of the Tc99-m sestamibi (Cardiolite) DRUG

Researchers will administer half of the radiotracer (Cardiolite), obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses.

Also known as: technetium (Tc-99m) sestamibi, Cardiolite

Half-dose radiotracer administration

Eligibility Criteria

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

You may qualify if:

• Patients over the age of 18 years
• Undergoing nuclear stress testing
• History of myocardial infarction, cardiomyopathy, heart failure or prior nuclear studies with resting perfusion defects

You may not qualify if:

• Unwilling or unable to undergo an additional resting SPECT acquisition
• Clinical contraindications to nuclear stress testing including acute myocardial infarction
• For patients undergoing exercise treadmill stress testing:
• Left bundle branch block or artificial ventricular pacemaker
• For patients undergoing regadenoson (Lexiscan) stress testing:
• Moderate to severe chronic obstructive pulmonary disease or asthma, second- or third degree atrioventricular block or sinus node disease (unless patients have a functioning artificial pacemaker), known hypersensitivity to aminophylline or adenosine
• Inability to give informed consent

Sponsors & Collaborators

• Edwin Wu: lead
• Astellas Pharma Global Development, Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Interventions

Technetium Tc 99m Sestamibi; Technetium

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Limitations and Caveats

Early termination of study lead to a small numbers of subjects analyzed. Technical problems in WBR processing settings including acquisition matrix sizes and/or number of iterations.

Results Point of Contact

• Title: Edwin Wu, MD
• Organization: Northwestern University

ed-wu@northwestern.edu

847-535-7270

Study Officials

• Edwin Wu, M.D., FACC

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine and Radiology

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 26, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Locations

US (1)