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

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ClinicalTrials.gov Identifier: NCT02130453
Recruitment Status : Recruiting
First Posted : May 5, 2014
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Astellas Scientific & Medical Affairs, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemia Drug: Regadenoson Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Use of Regadenoson for a Stress Echocardiogram Protocol Using Speckle Tracking Imaging
Actual Study Start Date : August 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: ReSTE Cardiac Imaging
Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.
Drug: Regadenoson
0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.

SPECT Cardiac Imaging
After resting strain measurement done, first set of nuclear images taken. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving Regadenoson, measurements repeated. These measurements take about 2 minutes to complete. At about 30 minutes after Regadenoson given, participant will have final images for the nuclear portion of the testing.
Drug: Regadenoson
0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.




Primary Outcome Measures :
  1. Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia [ Time Frame: 1 day ]
    As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.


Secondary Outcome Measures :
  1. Cardiac Event Rates After ReSTE and SPECT Imaging [ Time Frame: 30 days ]
    For secondary endpoints including cardiac event rates at Day 30 post-operation, estimates provided along with 95% confidence intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130453


Contacts
Contact: Jose Banchs, MD 713-792-6242

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Astellas Scientific & Medical Affairs, Inc.
Investigators
Principal Investigator: Jose Banchs, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02130453     History of Changes
Other Study ID Numbers: 2013-0881
NCI-2014-01162 ( Registry Identifier: NCI CTRP )
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Ischemia
Coronary artery disease
Nuclear stress test
Stress Echocardiogram
Echocardiography strain measurement
Ultrasound cardiac imaging
ReSTE
SPECT
Regadenoson

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs