Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
- Registration Number
- NCT02115308
- Lead Sponsor
- Timothy M. Bateman
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regadenoson Regadenoson Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
- Primary Outcome Measures
Name Time Method RADIAL STRAIN 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 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 Outcome Measures
Name Time Method Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain Day 1 For each subject, the 16-segments were visually assessed along the short-axis plane for the presence of LGE. These images were collected post regadenoson stress recovery using an inversion-recovery prepared, fast gradient echo sequence and a delay of at least 8 minutes after administration of a single dose of gadobenate dimeglumine.
The presence of LGE within a segment is a separate classification of segment type. The segment classifications in the other outcomes are determined from the prior positron-emission-tomography (PET) examination where the LGE determination is based solely on cardiac magnetic resonance (CMR) imaging collected data.
The measurement was performed to determine if the presence of LGE within a particular segment affect the resulting strain?Adverse Events Day 1 Adverse events were monitored and recorded on a specific Adverse Event (AE) log.
Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain Day 1 The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain
Trial Locations
- Locations (1)
Saint Luke's Health System
🇺🇸Kansas City, Missouri, United States