Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, LexiscanPhase 4ASSUAGENCT01250496

Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

A Phase 4 study testing Aminophylline in people with Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan, run by Rush University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
What is being tested?: Aminophylline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 248 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Nov 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center

Who cannot join

Patient refusal to participate
Known allergic reaction to aminophylline.
Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.
Pregnant or breast-feeding women.
Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: A Randomized Double-Blind Placebo Controlled Study With Aminophylline to Attenuate the Side Effect Profile of Regadenoson in Patients Undergoing Myocardial Perfusion Imaging.

Read the detailed description

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).

Conditions: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Being tested: Aminophylline, Placebo
Keywords: regadenoson, lexiscan, aminophylline, SPECT, Myocardial Perfusion Imaging, pharmacologic stress test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AminophyllineDrug
75 mg of intravenous aminophylline
PlaceboDrug
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Study groups in NCT01250496
Study group	Role	What they receive
Aminophylline	Experimental	75 mg of intravenous aminophylline. Receives: Drug: Aminophylline
Placebo	Placebo comparator	Matching normal saline placebo (sterile salt water). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: within 2 hours from the intervention.

Secondary outcomes (1)

"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.
Measured: within 2 hours from the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Nov 2011

First posted30 Nov 2010 (estimated)
Study startNov 2010
Primary completionNov 2011
Study completionNov 2011

Why it stopped: Due to nationwide shortage of Aminophylline. Enrolled subjects did not complete study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, LexiscanStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01250496
Sponsor's protocol ID: ASSUAGETrial
Acronym: ASSUAGE
Status last verified: Feb 2023
First submitted: 29 Nov 2010
Last updated: 13 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 22395779
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.
PubMed 24519563

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-Blind Placebo Controlled Study With Aminophylline to Attenuate the Side Effect Profile of Regadenoson in Patients Undergoing Myocardial Perfusion Imaging.
ClinicalTrials.gov ID: NCT01250496
Acronym / sponsor ID: ASSUAGE / ASSUAGETrial
Conditions: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Keywords: regadenoson, lexiscan, aminophylline, SPECT, Myocardial Perfusion Imaging, pharmacologic stress test
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to nationwide shortage of Aminophylline. Enrolled subjects did not complete study.
Enrolment: 248 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: Nov 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 30 Nov 2010 (estimated)
Results: Posted 13 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aminophylline	Experimental	Drug: Aminophylline75 mg of intravenous aminophylline.
Placebo	Placebo comparator	Drug: PlaceboMatching normal saline placebo (sterile salt water).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center

Key exclusion criteria (7 listed)

Patient refusal to participate
Known allergic reaction to aminophylline.
Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aminophylline75 mg of intravenous aminophylline	Drug	Aminophylline
PlaceboMatching 0.9 Normal Saline (sterile salt water)administered intravenously.	Drug	Placebo

Primary outcome

Composite Endpoints of Abdominal Cramps and Diarrhea.
Time frame: within 2 hours from the intervention.
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.

1 secondary outcome

"Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.
Time frame: within 2 hours from the intervention.

Results and safety

Results posted to the registry on 13 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aminophylline	124	0
Placebo	124	0

Primary outcome: Composite Endpoints of Abdominal Cramps and Diarrhea.

Time frame: within 2 hours from the intervention.. Count of participants. Unit: Participants

Measure	Aminophylline n = 124	Placebo n = 124
Value	11	22

Aminophylline vs Placebo: Odds Ratio (OR): 0.45 (95% CI 0.2 to 0.98), p = 0.04, Chi-squared

Population analysed: All enrolled patients who received the intervention (n=248; 124 aminophylline ans 124 placebo).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aminophylline	0 of 124 (0%)	55 of 124 (44.4%)	0 of 124
Placebo	0 of 124 (0%)	83 of 124 (66.9%)	0 of 124

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22395779Doukky 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.
Derived from this study: PubMed 24519563Ballany 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.
Pubmed abstractLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoints of Abdominal Cramps and Diarrhea. (time frame: within 2 hours from the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01250496, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.