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

• ClinicalTrials.gov Identifier: NCT01499654
• Recruitment Status: Terminated
• First Posted: December 26, 2011
• Results First Posted: February 24, 2016
• Last Update Posted: February 24, 2016
• Sponsor: Edwin Wu
• Collaborator: Astellas Pharma Global Development, Inc.
• Information provided by (Responsible Party): Edwin Wu, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction; Ischemic Heart Disease	Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction
• Study Start Date: October 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. Sum Rest Score [ Time Frame: Baseline ]
   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.
2. Segments With Resting Perfusion Defect [ Time Frame: Baseline ]
   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 :

1. Image Quality Score [ Time Frame: Baseline ]
   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).
2. Diagnostic Confidence Score [ Time Frame: Baseline ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: STU53243
• First Posted: December 26, 2011
• Results First Posted: February 24, 2016
• Last Update Posted: February 24, 2016
• Last Verified: January 2016

Keywords provided by Edwin Wu, Northwestern University:

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

Additional relevant MeSH terms:

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