Phase 4
N=40
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02115308 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: RADIAL STRAIN — 0.158; 0.149; 0.150; 0.190 unitless (strain) — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regadenoson (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Timothy M. Bateman
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RADIAL STRAIN |
0.158; 0.149; 0.150; 0.190; 0.167; 0.141 | 0.001 sig |
| PRIMARY CIRCUMFERENTIAL STRAIN |
-0.181; -0.140; -0.121; -0.169; -0.150; -0.126 | 0.011 sig |
| SECONDARY Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain |
0.157; 0.155; 0.140; 0.190; 0.185; 0.132 | 0.001 sig |
| SECONDARY Adverse Events |
7; 29; 0 | — |
| SECONDARY Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain |
-0.181; -0.139; -0.101; -0.169; -0.150; -0.111 | 0.008 sig |
Summary
The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.
Eligibility Criteria
Inclusion Criteria
- Myocardial rest/regadenoson stress perfusion PET study within 60 days
- Normal rest LVEF (greater than or equal to 50%)
- No change in symptoms or treatment between the PET and the MRI study
- Willing to consent to the study
- Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.
Exclusion Criteria
- Renal dysfunction (estimated glomerular filtration rate 60 cm, weight > 136 kg)
- History of gadolinium contrast allergy or intolerance
- Second or third degree AV block
- Sinus node dysfunction
- Acute myocardial infarction (past 3 months)
- Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days
- Patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson
Data sourced from ClinicalTrials.gov (NCT02115308). 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.