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Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Panithaya Chareonthaitawee, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01370265
First received: June 6, 2011
Last updated: September 3, 2013
Last verified: September 2013
Results First Received: October 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Interventions: Drug: Regadenoson
Drug: Adenosine
Drug: N-13 ammonia

  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
From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.

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
Regadenoson, Then Adenosine Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Adenosine, Then Regadenoson Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.

Participant Flow for 5 periods

Period 1:   Resting Myocardial Blood Flow (MBF)
    Regadenoson, Then Adenosine     Adenosine, Then Regadenoson  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 2:   Washout Period (50-minute Period Decay)
    Regadenoson, Then Adenosine     Adenosine, Then Regadenoson  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 3:   First Intervention
    Regadenoson, Then Adenosine     Adenosine, Then Regadenoson  
STARTED     6     6  
COMPLETED     5     5  
NOT COMPLETED     1     1  
Adverse Event                 1                 1  

Period 4:   Washout Period (50-minute Period Decay)
    Regadenoson, Then Adenosine     Adenosine, Then Regadenoson  
STARTED     5     5  
COMPLETED     5     5  
NOT COMPLETED     0     0  

Period 5:   Second Intervention
    Regadenoson, Then Adenosine     Adenosine, Then Regadenoson  
STARTED     5     5  
COMPLETED     5     5  
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.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive Regadenoson first and Adenosine first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 8  
Gender  
[units: participants]
 
Female     6  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     12  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  26.1  ± 4.3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Global Hyperemic Myocardial Blood Flow (MBF)   [ Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit ]

2.  Secondary:   Resting Global MBF and Resting Segmental MBF   [ Time Frame: Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit ]

3.  Secondary:   Global Cardiac Flow Rate   [ Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit ]

4.  Secondary:   Hyperemic Segmental MBF   [ Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit ]

5.  Secondary:   Segmental CFR   [ Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit ]

6.  Secondary:   Heart Rate (Beats Per Minute (BPM))   [ Time Frame: Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit ]

7.  Secondary:   Hyperemic Blood Pressure (mmHg)   [ Time Frame: Day 2, approximately 4 hours after arrival in the PET unit ]


  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
Small sample size; Subjects had no evidence of overt coronary artery disease, occult coronary artery disease affecting stress drug induced hyperemic PET MBF is a possibility; however, hyperemic MBF with both stress drugs would be equally affected.


  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: Dr. Panithaya Chareonthaitawee
Organization: Mayo Clinic
phone: 507-284-1648
e-mail: chareonthaitawee.panithaya@mayo.edu


No publications provided


Responsible Party: Panithaya Chareonthaitawee, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370265     History of Changes
Other Study ID Numbers: 10-006377
Study First Received: June 6, 2011
Results First Received: October 6, 2012
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration