Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
Condition: Cardiac Function
Study type: Interventional

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.
    

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.
    

Intervention name(s): regadenoson
Intervention type(s): Drug
Intervention description(s): Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.
Intervention MeSH terms: Regadenoson
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Regadenoson; 85% predicted heart rate; Myocardial perfusion stress testing