Phase 4
N=134
Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking
Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02130453 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia — 0.1538; 0.2308 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regadenoson (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia |
0.1538; 0.2308 | — |
| SECONDARY Cardiac Event Rates After ReSTE and SPECT Imaging |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent.
- 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.
- 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.
- Age 18 - 80 years.
Exclusion Criteria
- 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.
- Any patient with tachycardia defined as HR of 100 or higher at the day of SPECT will not be eligible for this study.
- Second- or third- degree AV block.
- Sinus node dysfunction.
- Patients with allergy to regadenoson.
- Patients with LBBB and/or artificial pacemaker.
Data sourced from ClinicalTrials.gov (NCT02130453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.