Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01026012
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2009-11-30
Brief Title:
Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rega Stress
Brief 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 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
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 observationmonitoring 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
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 observationmonitoring 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None