Cardiac FunctionRega StressNCT01026012
Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
A study testing regadenoson in people with Cardiac Function, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
It is been known for at least 20 years that the hemodynamic data, the amount of exercise performed as well as symptoms on the treadmill, has significant value to the perfusion stress testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6 minutes), this hemodynamic data is lost. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Function
- What is being tested?
- regadenoson
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for clinically indicated exercise stress Myocardial Perfusion Imaging (MPI) study, Provide written informed consent
- Provide written informed consent
Who cannot join
- 1. Acute myocardial infarction or unstable angina within three months 2 Any condition judged by the investigator likely to pose a safety risk to the patient 3 Participation in another investigational drug study within one month, Or participation in any previous rate adenosine trial 4 Females who are breast-feeding or pregnant 5 Dipyridamole use within 48 hours 6 Consumption of methyl xanthine's, coffee theophylline, caffeinated soft drinks chocolate within 24 hours of the stress test 7 Has received a heart transplant 8 Has a recent history (less than 30 days) of uncontrolled ventricular arrythmia 9 Active respiratory wheezing, angina, ventricular dysrhythmia, low blood pressure or EKG changes 10 Patients that do not have a functioning artificial pacemaker and have either: 1) second or third degree atrialventicular block 2) sinus node dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of MD Cardiology Physicians
Westminster, Maryland, 21157
About this study
It is been known for at least 20 years that the hemodynamic data, the amount of exercise performed as well as symptoms on the treadmill, has significant value to the perfusion stress testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6 minutes), this hemodynamic data is lost. Because of this loss of valuable data, it is felt that there is also a loss of significant prognostic data as well. With the advent and FDA release of Regadenoson in a rapid injection form (over 10 seconds), it is thought that the combination of both exercise stress testing and pharmacologic testing in subjects that do not achieve 85% in a maximal predicted heart rate may be a viable stress testing option.
The purpose of this study is to look at using the drug, regadenoson, with exercise stress testing; and the side effect symptoms that may be experienced by individual subjects using this combination.
Read the detailed description
A nuclear stress test has been recommended for a patient by their doctor. This test helps to detect significant blockages in the artery to the heart. The test involves the patient walking on a treadmill until their heart rate reaches 85% of their age-determined maximal predicted heart rate. If the patient needs to stop walking for any reason (tiredness, chest pain, shortness of breath or dizziness) prior to reaching the 85% of their maximal heart rate, then the test becomes inaccurate and blockages can be missed. Nonetheless, the information that we gain from the patient walking remains valuable.
If the subject does not reach 85%, the usual procedure is to re-do the test where the subject would not walk on the treadmill, but would be injected with a pharmacologic agent (drug) which dilates their blood vessels. This would allow us to obtain an accurate picture about any blockages in the blood vessels. By doing the "drug" test alone, we lose the important information gained by the treadmill test.
In the present study the subject will be asked to walk on the treadmill and near the end of the walk, if they do not reach 85%, then the "drug" will be given to the patient. Regadenoson is FDA approved for drug stress testing. Regadenoson (versus one of the other pharmacological agents) will be given at a dose of 400 mcg, will be infused over 10 - 20 seconds followed by standard flushing solution, and then the infusion of a radiotracer (the FDA approved method of administration) will be given for nuclear imaging. The entire intravenous procedure takes 30 seconds. The subject will then undergo 5 minutes of standard observation/monitoring post infusion administration. Standard nuclear stress imaging will then follow. By doing this, we will obtain all the important information from the exercise portion of this test and maintain the accuracy to detect blockages. By doing the study in this manner, we will be able to save the subject time and obtain more information about the heart than either test individually.
- Conditions
- Cardiac Function
- Being tested
- regadenoson
- Keywords
- Regadenoson, 85% predicted heart rate, Myocardial perfusion stress testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regadenosonDrug
Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.
| Study group | Role | What they receive |
|---|---|---|
| Combined Protocol | Experimental | patient with submaximal symptom limited maximal exercise testing will also be administered regadenoson pharmacological stress test. Receives: Drug: regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.
Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)
Measured: During and 30 minutes after stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
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.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Scott Jerome, University of Maryland, Baltimore
- Investigators
- Scott Jerome, D.O., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026012
- Sponsor's protocol ID
- HP-00040189
- Acronym
- Rega Stress
- Status last verified
- Jul 2022
- First submitted
- 30 Nov 2009
- Last updated
- 2 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
- ClinicalTrials.gov ID
- NCT01026012
- Acronym / sponsor ID
- Rega Stress / HP-00040189
- Conditions
- Cardiac Function
- Keywords
- Regadenoson, 85% predicted heart rate, Myocardial perfusion stress testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is been known for at least 20 years that the hemodynamic data, the amount of exercise performed as well as symptoms on the treadmill, has significant value to the perfusion stress testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6 minutes), this hemodynamic data is lost. Because of this loss of valuable data, it is felt that there is also a loss of significant prognostic data as well. With the advent and FDA release of Regadenoson in a rapid injection form (over 10 seconds), it is thought that the combination of both exercise stress testing and pharmacologic testing in subjects that do not achieve 85% in a maximal predicted heart rate may be a viable stress testing option.
The purpose of this study is to look at using the drug, regadenoson, with exercise stress testing; and the side effect symptoms that may be experienced by individual subjects using this combination.
Detailed description
A nuclear stress test has been recommended for a patient by their doctor. This test helps to detect significant blockages in the artery to the heart. The test involves the patient walking on a treadmill until their heart rate reaches 85% of their age-determined maximal predicted heart rate. If the patient needs to stop walking for any reason (tiredness, chest pain, shortness of breath or dizziness) prior to reaching the 85% of their maximal heart rate, then the test becomes inaccurate and blockages can be missed. Nonetheless, the information that we gain from the patient walking remains valuable.
If the subject does not reach 85%, the usual procedure is to re-do the test where the subject would not walk on the treadmill, but would be injected with a pharmacologic agent (drug) which dilates their blood vessels. This would allow us to obtain an accurate picture about any blockages in the blood vessels. By doing the "drug" test alone, we lose the important information gained by the treadmill test.
In the present study the subject will be asked to walk on the treadmill and near the end of the walk, if they do not reach 85%, then the "drug" will be given to the patient. Regadenoson is FDA approved for drug stress testing. Regadenoson (versus one of the other pharmacological agents) will be given at a dose of 400 mcg, will be infused over 10 - 20 seconds followed by standard flushing solution, and then the infusion of a radiotracer (the FDA approved method of administration) will be given for nuclear imaging. The entire intravenous procedure takes 30 seconds. The subject will then undergo 5 minutes of standard observation/monitoring post infusion administration. Standard nuclear stress imaging will then follow. By doing this, we will obtain all the important information from the exercise portion of this test and maintain the accuracy to detect blockages. By doing the study in this manner, we will be able to save the subject time and obtain more information about the heart than either test individually.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Protocol | Experimental | Drug: regadenosonpatient with submaximal symptom limited maximal exercise testing will also be administered regadenoson pharmacological stress test. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred for clinically indicated exercise stress Myocardial Perfusion Imaging (MPI) study, Provide written informed consent
- Provide written informed consent
Key exclusion criteria (1 listed)
- 1. Acute myocardial infarction or unstable angina within three months 2 Any condition judged by the investigator likely to pose a safety risk to the patient 3 Participation in another investigational drug study within one month, Or participation in any previous rate adenosine trial 4 Females who are breast-feeding or pregnant 5 Dipyridamole use within 48 hours 6 Consumption of methyl xanthine's, coffee theophylline, caffeinated soft drinks chocolate within 24 hours of the stress test 7 Has received a heart transplant 8 Has a recent history (less than 30 days) of uncontrolled ventricular arrythmia 9 Active respiratory wheezing, angina, ventricular dysrhythmia, low blood pressure or EKG changes 10 Patients that do not have a functioning artificial pacemaker and have either: 1) second or third degree atrialventicular block 2) sinus node dysfunction
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 |
|---|---|---|
| regadenosonRegadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush. | Drug | Combined Protocol |
Primary outcome
Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.
Time frame: During and 30 minutes after stress test
Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott Jerome, D.O. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regadenoson in people with Cardiac Function, run by University of Maryland, Baltimore 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Aug 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2014). 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?
Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others. (time frame: During and 30 minutes after stress test). 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 2 Aug 2022.