NCT02130453

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ischemia

Interventions

Type	Name	Description
DRUG	Regadenoson	0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.

Timeline

• Start date: 2014-09-30
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2014-05-05
• Last updated: 2024-10-02
• Results posted: 2024-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study