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Due to nationwide shortage of Aminophylline. Enrolled subjects did not complete study.
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The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.
Approximately 250 patients who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminophylline | Experimental | 75 mg of intravenous aminophylline. |
|
| Placebo | Placebo Comparator | Matching normal saline placebo (sterile salt water). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminophylline | Drug | 75 mg of intravenous aminophylline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoints of Abdominal Cramps and Diarrhea. | Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory. | within 2 hours from the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| "Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects. | The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted. | within 2 hours from the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22395779 | Result | Doukky R, Morales Demori R, Jain S, Kiriakos R, Mwansa V, Calvin JE. Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial". J Nucl Cardiol. 2012 Jun;19(3):448-57. doi: 10.1007/s12350-012-9533-x. Epub 2012 Mar 7. | |
| 24519563 |
| Label | URL |
|---|---|
| Pubmed abstract | View source |
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Two consenting subjects did not undergo regadenoson-stress for a clinical reason and were subsequently excluded.
Otherwise, the remainder of connecting patients received the intervention they are allocated to, completed follow-up and analyzed within the group they were randomized to.
Recruitment took place at the stress testing laboratories of Rush University Medical Center in the period from November 23, 2010 through February 10, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aminophylline | 75 mg of intravenous aminophylline. |
| FG001 | Placebo | Matching normal saline placebo (sterile salt water). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aminophylline | 75 mg of intravenous aminophylline. |
| BG001 | Placebo | Matching normal saline placebo (sterile salt water). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Endpoints of Abdominal Cramps and Diarrhea. | Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory. | All enrolled patients who received the intervention (n=248; 124 aminophylline ans 124 placebo). | Posted | Count of Participants | Participants | within 2 hours from the intervention. |
|
24 hours
Clinically determined adverse events that require treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aminophylline | 75 mg of intravenous aminophylline. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachyarrhythmia | Cardiac disorders | Systematic Assessment | Any treatment-requiring tachyarrhythmia that was not present at baseline occurring in the 24 hours ensuing the regadenoson stress test. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment | Flushing sensation occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rami Doukky; Director of Nuclear Cardiology | Rush University Medical Center | 312-942-4655 | rami_doukky@rush.edu |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| Placebo |
| Drug |
Matching 0.9 Normal Saline (sterile salt water)administered intravenously. |
|
| Ballany W, Mansour K, Morales Demori R, Al-Amoodi M, Doukky R. The impact of regimented aminophylline use on extracardiac radioisotope activity in patients undergoing regadenoson stress SPECT myocardial perfusion imaging: a substudy of the ASSUAGE trial. J Nucl Cardiol. 2014 Jun;21(3):496-502. doi: 10.1007/s12350-014-9864-x. Epub 2014 Feb 12. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | "Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects. | The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted. | All enrolled patients who received the intervention (n= 248; 124 aminophyllineand and 124 placebo). | Posted | Number | participants | within 2 hours from the intervention. |
|
|
|
|
| 124 |
| 0 |
| 124 |
| 55 |
| 124 |
| EG001 | Placebo | Matching normal saline placebo (sterile salt water). | 0 | 124 | 0 | 124 | 83 | 124 |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment | Events of cardiac arrest due to ventricular tachycardia, ventricular fibrillation, asystole, or pulseless electrical activity that lead to the initiation of Advanced Cardiac Life Support protocol in the 24 hours ensuing the regadenoson stress test. |
|
| Hospitalization | General disorders | Systematic Assessment | Any event leading to patient hospitalization from any cause in the 24 hours ensuing the regadenoson stress test. |
|
| Seizure | Nervous system disorders | Systematic Assessment | Any seizure event in the 24 hours ensuing the regadenoson stress test. |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Bronchospasm or auscultatory wheezing with shortness of breath occurring in the 24 hours following regadenoson administration |
|
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnea sensation occuring any time after the administration of regadenoson until the patient's dismissal from the nuclear laboratory. |
|
| Headache | Nervous system disorders | Systematic Assessment | Headache symptoms occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Chest discomfort or pain | Cardiac disorders | Systematic Assessment | Chest discomfort occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Angina | Cardiac disorders | Systematic Assessment | Angina symptoms occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Feeling hot | Skin and subcutaneous tissue disorders | Systematic Assessment | Hot sensation occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Abdominal cramp or discomfort | Gastrointestinal disorders | Systematic Assessment | Abdominal cramps or discomfort occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Dizziness | Nervous system disorders | Systematic Assessment | Dizziness symptoms occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea or loose bowel movement occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Open label aminophylline use | Injury, poisoning and procedural complications | Systematic Assessment | Intravenous aminophylline to treat regadenoson-related side effects, administered after regadenoson injection |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Self-limiting atrial fibrillation, not requiring treatment, occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment | Self-limiting supraventricular tachycardia, not requiring treatment, occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
| Non-sustained ventricular tachycardia | Cardiac disorders | Systematic Assessment | Self-limiting non-sustained ventricular tachycardia, not requiring treatment, occurring anytime after the administration of regadenoson until the patient's dismissal from the nuclear laboratory |
|
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| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |