NCT01336140|CompletedPhase 4ResultsDMC
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
ASSUAGE-CKD
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Sponsor study identifier
Secondary identifiers
OTHER · FDA - IND
interventional
300
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)The routine administration of 75 mg of intravenous aminophylline in patients with severe chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2011
Actual (reported)April 15, 2011
Actual (reported)June 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2012
Actual (reported)May 2012
Actual (reported)February 13, 2013
Actual (reported)Diarrhea (as Reported by the Patient)
Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion). The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements.
Within 2 hours from the intervention
Number of Patients With Any (One or More) Regadenoson-related Adverse-effect
Within 2 hours from the intervention.
Global Symptom Score (GSS) of Regadenoson Related Adverse-effects
Within 2 hours from the intervention.
75 mg of intravenous aminophylline.
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
75 mg of intravenous aminophylline
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rush University Medical Center
Chicago, Illinois, 60612, United States
Doukky R, Rangel MO, Dick R, Wassouf M, Alqaid A, Margeta B. Attenuation of the side effect profile of regadenoson: a randomized double-blind placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging and have severe chronic kidney disease--the ASSUAGE-CKD trial. Int J Cardiovasc Imaging. 2013 Jun;29(5):1029-37. doi: 10.1007/s10554-012-0166-6. Epub 2012 Dec 11.
Rami Doukky, MD
Rush University Medical Center
300 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2011
First Posted
April 15, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
Patients With Recorded Aminophylline Related Major Adverse Events
Within 24 hours from the intervention.
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
January 26, 2023
Results First Posted
February 13, 2013
Record last verified: 2023-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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