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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
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Myocardial Infarction
Ischemic Heart Disease
Intervention: Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prospectively enroll patients with history of severe myocardial infarction, cardiomyopathy, heart failure or prior nuclear scans with resting perfusion defects. Patients were approached in the nuclear stress lab prior to scheduled stress test. Recruitment period was between 3/20/2012 and 2/14/2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Group Entire cohort

Participant Flow:   Overall Study
    Study Group
STARTED   64 
COMPLETED   64 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Group Entire cohort

Baseline Measures
   Study Group 
Overall Participants Analyzed 
[Units: Participants]
 64 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (11) 
Gender 
[Units: Participants]
 
Female   16 
Male   48 
Height 
[Units: Inches]
Mean (Standard Deviation)
 68.0  (4.1) 
Weight 
[Units: Pounds]
Mean (Standard Deviation)
 198.4  (40.0) 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.2  (6.0) 
Indications for stress test 
[Units: Participants]
 
Chest pain   16 
Dyspnea   9 
Prior Myocardial Infarct   7 
Prior Coronary Disease   18 
Cardiomyopathy   5 
CHF   6 
Prior CABG   8 
Prior PCI   5 
Other   9 
History 
[Units: Participants]
 
Hypertension   58 
Hypercholesterolemia   52 
Tobacco smoking (prior or current)   24 
Diabetes mellitus   21 
Family history of CAD   19 
Prior Myocardial Infarct   28 
Coronary artery disease   46 
Coronary artery bypass surgery   27 
Previous nuclear stress 
[Units: Participants]
 39 
Medications 
[Units: Participants]
 
ACE inhibitors/ARB   33 
Beta-blockers   56 
Ca-channel blockers   19 
Aspirin   51 
Anti-platelet   21 
Statin   53 
Nitrates   11 
Diuretic   24 


  Outcome Measures
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1.  Primary:   Sum Rest Score   [ Time Frame: Baseline ]

2.  Primary:   Segments With Resting Perfusion Defect   [ Time Frame: Baseline ]

3.  Secondary:   Image Quality Score   [ Time Frame: Baseline ]

4.  Secondary:   Diagnostic Confidence Score   [ Time Frame: Baseline ]

5.  Post-Hoc:   Resting Full-Tracer Dose   [ Time Frame: Baseline ]

6.  Post-Hoc:   Injection and Scan Times   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edwin Wu, MD
Organization: Northwestern University
phone: 847-535-7270
e-mail: ed-wu@northwestern.edu



Responsible Party: Edwin Wu, 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