NCT01250496

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

March 13, 2023

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

November 29, 2010

Results QC Date

November 29, 2012

Last Update Submit

February 14, 2023

Conditions

Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan

Keywords

regadenosonlexiscanaminophyllineSPECTMyocardial Perfusion Imagingpharmacologic stress test

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • "Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.

    within 2 hours from the intervention.

Study Arms (2)

Aminophylline

EXPERIMENTAL

75 mg of intravenous aminophylline.

Drug: Aminophylline

Placebo

PLACEBO COMPARATOR

Matching normal saline placebo (sterile salt water).

Drug: Placebo

Interventions

AminophyllineDRUG

75 mg of intravenous aminophylline

Aminophylline
PlaceboDRUG

Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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®).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • 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.

    PMID: 22395779RESULT

  • 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.

    PMID: 24519563DERIVED

Related Links

MeSH Terms

Interventions

Aminophylline

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Rami Doukky; Director of Nuclear Cardiology
Organization
Rush University Medical Center
rami_doukky@rush.edu
312-942-4655

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nuclear Cardiology and Stress Testing Laboratories

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 13, 2023

Results First Posted

March 13, 2023

Record last verified: 2023-02

Locations

US(1)