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Clinical Trial Details

Trial ID: L1675
Source ID: NCT01336140
Associated Drug: Aminophylline
Title: Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Acronym: ASSUAGE-CKD
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01336140/results
Conditions: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Interventions: DRUG: Aminophylline|DRUG: Placebo
Outcome Measures: Primary: 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 | Secondary: Number of Patients With Any (One or More) Regadenoson-related Adverse-effect, Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea. When multiple adverse effects are reported, only one event is counted., Within 2 hours from the intervention.|Global Symptom Score (GSS) of Regadenoson Related Adverse-effects, GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea. GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above). The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus: Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30, Within 2 hours from the intervention.|Patients With Recorded Aminophylline Related Major Adverse Events, Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure \< 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure., Within 24 hours from the intervention.
Sponsor/Collaborators: Sponsor: Rush University Medical Center | Collaborators: Cook County Health
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2011-06
Completion Date: 2012-05
Results First Posted: 2013-02-13
Last Update Posted: 2023-01-26
Locations: Rush University Medical Center, Chicago, Illinois, 60612, United States
URL: https://clinicaltrials.gov/show/NCT01336140