Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- RADIAL STRAIN
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 mL/min/1.73m2) within 6 months
- •Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
- •Patient size exceeds MRI bore/table limits: (Max body diameter > 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
Arms & Interventions
Regadenoson
Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
Intervention: Regadenoson (Drug)
Outcomes
Primary Outcomes
RADIAL STRAIN
Time Frame: Day 1
A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.
CIRCUMFERENTIAL STRAIN
Time Frame: Day 1
A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless.
Secondary Outcomes
- Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain(Day 1)
- Adverse Events(Day 1)
- Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain(Day 1)
Investigators
Timothy M. Bateman
Medical Director
Aspire Foundation