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Half-Dose Radiopharmaceutical in Wide Beam Reconstruction (REGA-1102)

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Edwin Wu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01499654
First received: December 19, 2011
Last updated: January 27, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention
Myocardial Infarction
Ischemic Heart Disease
Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Sum Rest Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Segments With Resting Perfusion Defect [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Image Quality Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).

  • Diagnostic Confidence Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).


Enrollment: 64
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Half-dose radiotracer administration
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)
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.
Other Name: technetium (Tc-99m) sestamibi, Cardiolite

Detailed Description:

Subjects in this study will proceed to the nuclear cardiology laboratory for their scheduled nuclear stress test. After informed consent is obtained, the study doctor or research staff member will ask detailed questions about the subject's current health, medications and medical history, and the subject's medical chart will be reviewed including results of any previous nuclear images.

For the test, a small catheter (tube) will be placed in a vein in the subject's arm to administer the radioactive imaging agent, Tc-99m sestamibi. Subjects will be given half (1/2) of the normal Tc-99m sestamibi dose and then the study staff will obtain resting images pictures of the heart. After this set of images, the subject will be given the remaining half of the radioactive imaging agent followed by a second set of images.

After this, the subject will then undergo the stress portion of the test in the usual manner as prescribed by the referring physician.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499654

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Edwin Wu
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: Edwin Wu, M.D., FACC Northwestern University
  More Information

Responsible Party: Edwin Wu, Associate Professor of Medicine and Radiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01499654     History of Changes
Other Study ID Numbers: STU53243 
Study First Received: December 19, 2011
Results First Received: December 18, 2015
Last Updated: January 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
SPECT MPI
Tomography, Emission-Computed, Single-Photon
Wide Beam Reconstruction

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Radiopharmaceuticals
Technetium Tc 99m Sestamibi
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016