Clinical trial

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

Name
2013-0881
Description
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.
Trial arms
Trial start
2014-08-28
Estimated PCD
2024-08-31
Trial end
2024-08-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Regadenoson
0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.
Arms:
ReSTE Cardiac Imaging, SPECT Cardiac Imaging
Size
300
Primary endpoint
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia
1 day
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-02-14

1 organization

1 product

1 indication

Indication
Ischemia