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  
Number of Participants  
[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  
Indication for Stress Testing [2]
[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] History of either myocardial infarction or coronary revascularization
[2] 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