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Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01021618
First received: November 25, 2009
Last updated: March 18, 2013
Last verified: March 2013
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Coronary Artery Disease
Myocardial Ischemia
Interventions: Drug: Regadenoson
Other: Symptom-limited exercise

  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
Recruitment took place in the Hartford Hospital Nuclear Cardiology Laboratory from January 2010 and February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the onset of the study, only subjects with scores greater than or equal to 9.95 were randomized. After the first 96 patients had been screened and 55 randomized with no adverse events in the study group, this restriction was removed.

Reporting Groups
  Description
Vasodilator-exercise Stress Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
Exercise-vasodilator Stress Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint

Participant Flow:   Overall Study
    Vasodilator-exercise Stress   Exercise-vasodilator Stress
STARTED   44   96 
COMPLETED   44   96 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
Vasodilator-exercise Stress Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
Exercise-vasodilator Stress Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
Total Total of all reporting groups

Baseline Measures
   Vasodilator-exercise Stress   Exercise-vasodilator Stress   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   96   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (13)   63  (11)   62  (12) 
Gender 
[Units: Participants]
     
Female   23   44   67 
Male   21   52   73 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   21   50   71 
Hispanic   13   24   37 
Black   8   19   27 
Other   2   3   5 
Known Coronary Artery Disease [1] 
[Units: Participants]
     
Any known coronary disease   15   29   44 
No known coronary disease   29   67   96 
[1] History of either myocardial infarction or coronary revascularization
Indication for Stress Testing [1] 
[Units: Participants]
     
Chest Pain   36   71   107 
Dyspnea   4   8   12 
Arrhythmia   1   7   8 
Syncope or Near-Syncope   2   4   6 
Other   1   6   7 
[1] Clinical indication for referral to the nuclear laboratory for stress testing, from the referring clinician


  Outcome Measures
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1.  Primary:   Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire   [ Time Frame: 24 hours ]

2.  Secondary:   Myocardial Perfusion Image Quality   [ Time Frame: 0 hours ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gary V Heller, MD, PhD
Organization: Hartford Hospital
phone: 860-545-5527
e-mail: aahlber@harthosp.org


Publications:

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01021618     History of Changes
Other Study ID Numbers: HELL002965HI
Study First Received: November 25, 2009
Results First Received: October 23, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration