Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01026012 |
Other study ID # |
HP-00040189 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2009 |
Est. completion date |
September 2010 |
Study information
Verified date |
July 2022 |
Source |
University of Maryland, Baltimore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.