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

December 19, 2011
January 27, 2016
October 2011
December 2014   (final data collection date for primary outcome measure)
  • 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.
image quality [ Time Frame: Subject participation is complete following imaging portion of stress test. Data will be collected and images compared within 24 hours of testing. All images will be analyzed and compared at the completion of the study, est. Feb, 2013 ] [ Designated as safety issue: No ]
SPECT images will be randomized and de-identified. Each subject will have 3 images in combinations of radiopharmaceutical dose and reconstruction algorithm for analysis. Perfusion data will be reported using a 17-segment model and scored on a scale between 0 and 4. Scores will be obtained semi-quantitatively by 2 expert readers. The sum of the scores over 17 segments will be summed to report the summed rest score (SRS). Additionally, images will be classified as diagnostic vs. non-diagnostic and the quality of the images will be graded on a scale from 0 to 3.
Complete list of historical versions of study NCT01499654 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Half-Dose Radiopharmaceutical in Wide Beam Reconstruction
Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Myocardial Infarction
  • Ischemic Heart Disease
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
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.
Intervention: Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01499654
STU53243
No
Not Provided
Not Provided
Edwin Wu, Northwestern University
Edwin Wu
Astellas Pharma Global Development, Inc.
Principal Investigator: Edwin Wu, M.D., FACC Northwestern University
Northwestern University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP