Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/24/2019
Start Date:August 2014
End Date:August 2020

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Use of Regadenoson for a Stress Echocardiogram Protocol Using Speckle Tracking Imaging

The goal of this clinical research study is to compare regadenoson nuclear stress testing
with echocardiography strain measurements (an ultrasound imaging method that measures hearts
function) in detecting coronary artery disease.

If you agree to take part in this study, you will have the echocardiography strain
measurement performed. This will be done while you lie on an exam table. An ultrasound
technician will apply a vaseline-like gel to your chest and will take the measurements by
holding a transducer (a device that resembles a microphone) against your chest, sliding it
back and forth. This will take about 10 minutes.

After the resting strain measurement is done, you will have the first set of nuclear images.
This will be done just like the echocardiography strain measurement. Once these images are
completed, you will be given regadenoson by vein over about 10 seconds. Within 2 to 4 minutes
of receiving the regadenoson, measurements will be repeated. These measurements will take
about 2 minutes to complete. At about 30 minutes after regadenoson was given, you will have
the final images for the nuclear portion of the testing (this is the usual timing for nuclear
images after regadenoson).

You will receive the same treatment during your stress test, including the same amount of
regadenoson, as you would if you did not take part in this study. Some participants may be
asked to allow a repeat of the strain measurements that will include an additional dose of
regadenoson if the first set of images are not good enough and additional images may be
taken.

Length of Study:

Your participation on this study will be over 30 days after the tests OR after surgery,
whichever occurs later. Researchers will collect information from your medical record for up
to 30 days after your tests.

If you have surgery or are hospitalized in the 30 days after the tests, you will be called
and asked about any problems you have been having. This call should take about 10 minutes.

This is an investigational study. Regadenoson is FDA approved and is routinely used for
nuclear perfusion stress testing. The use of strain measurement during an echocardiogram to
detect coronary disease is investigational.

Up to 300 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Cancer patients who are scheduled for (perfusion) nuclear stress testing using
regadenoson as stress agent.

2. Indications for stress testing is either: -as part of a pre-operative evaluation prior
to a planned cancer related surgery that is considered to be at least of intermediate
risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate
surgery) OR -as an evaluation in the cardiology clinic for symptoms described in a
cardiology consult as typical angina, or of significant suspicion for coronary disease
or symptoms described as likely of a cardiac/coronary etiology.

3. Patients with a history of LV dysfunction will be still candidates for enrollment in
the study if they have documented LVEF recovery (most recent documented LVEF of 50% or
higher) for at least 6 months prior to SPECT regardless of current cardiac medication
regimen.

4. Age 18 - 80 years.

Exclusion Criteria:

1. Patients consented for the trial that on the baseline 2D study have poor acoustic echo
windows (i.e. a reader is unable to see in definition 2 or more segments from the
apical views) will not be eligible to continue in the trial and peak hyperemia images
will not be obtained.

2. Any patient with tachycardia defined as HR of 100 or higher at the day of SPECT will
not be eligible for this study.

3. Second- or third- degree AV block.

4. Sinus node dysfunction.

5. Patients with allergy to regadenoson.

6. Patients with LBBB and/or artificial pacemaker.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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