Coronary Artery DiseasePhase 4ASSUAGE-MPINCT01655524
The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion
A Phase 4 study testing ASSUAGE Protocol in people with Coronary Artery Disease, run by Rush University Medical Center at 1 site in United States.
Trial summary
The investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The modified (ASSUAGE) protocol has been associated with fewer side effects and was better tolerated by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ASSUAGE Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test).
Who cannot join
- inability to provide an informed consent
- known allergic reaction to aminophylline or regadenoson
- systolic blood pressure < 90 mmHg
- unstable abnormal heart rhythm
- pulmonary edema
- acute coronary symptoms, myocardial infarction within 48 hours
Show all 9Show fewer
- active dipyridamole, aminophylline or theophylline use
- pregnancy
- any contraindication to aminophylline according to the drug's package insert: uncontrolled seizure disorder, sepsis with multi-organ failure and liver impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: The Impact of Routine Administration of Aminophylline Following Regadenoson According to the ASSUAGE Protocol on the Accuracy of Regadenoson Stress Myocardial Perfusion Imaging: A Single-Blinded Cross-Over Clinical Trial
The investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The modified (ASSUAGE) protocol has been associated with fewer side effects and was better tolerated by patients.
This study will investigate whether the modified regadenoson stress protocol (ASSUAGE) produces blood flow pattern to the heart similar to that of a standard regadenoson stress protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a wide scale instead of the current standard protocol.
Read the detailed description
Patients who had regadenoson stress nuclear stress test of the heart will be invited to return to undergo a modified nuclear stress using the modified (ASSUAGE) protocol. Images from the original scan will be compared to those from the second scan to determine whether the blood flow pattern is similar between the two scans.
- Conditions
- Coronary Artery Disease
- Being tested
- ASSUAGE Protocol
- Keywords
- Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSUAGE ProtocolDrug
Also called Aminophylline
75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.
| Study group | Role | What they receive |
|---|---|---|
| ASSUAGE Protocol | Experimental | There is only one arm in this cross-over design trial. Patients who had a standard regadenoson stress test will be invited to enroll in the study. All enrolled subjects will undergo an investigational (ASSUAGE) regadenoson stress test. Imaging scans from the same patients (scan 1 and scan 2) will be compared. Receives: Drug: ASSUAGE Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Difference Score (SDS); a measure of size and severity of ischemia (heart muscle in jeopardy) detected with regadenoson nuclear stress of the heart (standard vs. ASSUAGE protocol).
The SDS produced with standard protocol will be compared to SDS produced with the modified (ASSUAGE) protocol. The study is set out to demonstrate that there is no significant difference in SDS between the two protocols within the same patients.
Measured: The second (investigational) stress will be performed within 4 weeks from the intial one.
Secondary outcomes (1)
Agreement rate in the SDS burden category (normal/mild, moderate or severe)
Agreement rate in the SDS burden category (normal/mild, moderate or severe)between scan 1 and scan 2 will be compared to the agreement rate between 2 sets of images from scan 1. The study is set out to demonstrate that these agreement rates are not significantly different.
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Due to nationwide shortage of Aminophylline. No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami Doukky, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655524
- Sponsor's protocol ID
- ASSUAGE-MPI Trial
- Acronym
- ASSUAGE-MPI
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2012
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Routine Administration of Aminophylline Following Regadenoson According to the ASSUAGE Protocol on the Accuracy of Regadenoson Stress Myocardial Perfusion Imaging: A Single-Blinded Cross-Over Clinical Trial
- ClinicalTrials.gov ID
- NCT01655524
- Acronym / sponsor ID
- ASSUAGE-MPI / ASSUAGE-MPI Trial
- Conditions
- Coronary Artery Disease
- Keywords
- Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to nationwide shortage of Aminophylline. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The modified (ASSUAGE) protocol has been associated with fewer side effects and was better tolerated by patients.
This study will investigate whether the modified regadenoson stress protocol (ASSUAGE) produces blood flow pattern to the heart similar to that of a standard regadenoson stress protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a wide scale instead of the current standard protocol.
Detailed description
Patients who had regadenoson stress nuclear stress test of the heart will be invited to return to undergo a modified nuclear stress using the modified (ASSUAGE) protocol. Images from the original scan will be compared to those from the second scan to determine whether the blood flow pattern is similar between the two scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASSUAGE Protocol | Experimental | Drug: ASSUAGE ProtocolThere is only one arm in this cross-over design trial. Patients who had a standard regadenoson stress test will be invited to enroll in the study. All enrolled subjects will undergo an investigational (ASSUAGE) regadenoson stress test. Imaging scans from the same patients (scan 1 and scan 2) will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test).
Key exclusion criteria (9 listed)
- inability to provide an informed consent
- known allergic reaction to aminophylline or regadenoson
- systolic blood pressure < 90 mmHg
- unstable abnormal heart rhythm
- pulmonary edema
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 |
|---|---|---|
| ASSUAGE ProtocolAlso: Aminophylline75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart. | Drug | ASSUAGE Protocol |
Primary outcome
Summed Difference Score (SDS); a measure of size and severity of ischemia (heart muscle in jeopardy) detected with regadenoson nuclear stress of the heart (standard vs. ASSUAGE protocol).
Time frame: The second (investigational) stress will be performed within 4 weeks from the intial one.
The SDS produced with standard protocol will be compared to SDS produced with the modified (ASSUAGE) protocol. The study is set out to demonstrate that there is no significant difference in SDS between the two protocols within the same patients.
1 secondary outcome
Agreement rate in the SDS burden category (normal/mild, moderate or severe)
Time frame: within 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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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.
Rami Doukky, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ASSUAGE Protocol in people with Coronary Artery Disease, run by Rush University Medical Center at 1 site in United States.
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 9 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: withdrawn, as of the sponsor's last update on 11 Oct 2021. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Summed Difference Score (SDS); a measure of size and severity of ischemia (heart muscle in jeopardy) detected with regadenoson nuclear stress of the heart (standard vs. ASSUAGE protocol). (time frame: The second (investigational) stress will be performed within 4 weeks from the intial one.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2021.