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Trial record 70 of 1129 for:    adenosine

Effects of Body Mass Index on the Hyperemic Response to Regadenoson

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ClinicalTrials.gov Identifier: NCT00859833
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : May 24, 2011
Last Update Posted : May 24, 2011
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Conditions Obesity
Endothelial Dysfunction
Decreased Vascular Flow
Interventions Drug: Adenosine
Drug: Regadenoson
Enrollment 30
Recruitment Details Patients were recruited from medical clinics and by advertising within the hospital.
Pre-assignment Details  
Arm/Group Title Adenosine Followed by Regadenoson
Hide Arm/Group Description Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Adenosine Followed by Regadenoson
Hide Arm/Group Description Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
49.5  (11.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Between 18 and 65 years 30
>=65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)
Hide Description The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.
Arm/Group Title Adenosine Regadenoson
Hide Arm/Group Description:
Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
Regadenoson 0.5 mg i.v. bolus.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ratio
2.25  (0.59) 2.44  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine
Comments Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.
Statistical Test of Hypothesis P-Value 0.3617
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6041 to 0.2241
Parameter Dispersion
Type: Standard Deviation
Value: 0.7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine Followed by Regadenoson
Hide Arm/Group Description Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
All-Cause Mortality
Adenosine Followed by Regadenoson
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine Followed by Regadenoson
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adenosine Followed by Regadenoson
Affected / at Risk (%)
Total   0/30 (0.00%) 
Due to technical problems, data from two of the 30 subjects was not usable.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Sheldon Litwin
Organization: Univesity of Utah
Phone: 801-581-7715
Responsible Party: Sheldon Litwin, M.D., Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT00859833     History of Changes
Other Study ID Numbers: 31431
First Submitted: March 10, 2009
First Posted: March 11, 2009
Results First Submitted: November 1, 2010
Results First Posted: May 24, 2011
Last Update Posted: May 24, 2011