Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

Study Overview
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Brief Summary
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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.

Official Title
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Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Regadenoson


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regadenoson<br>Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson. | Drug: Regadenoson<br>* Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.<br>* Other names: Lexiscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RADIAL STRAIN | 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. | Day 1 | 
| CIRCUMFERENTIAL STRAIN | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain | 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? | Day 1 | 
| Adverse Events | Adverse events were monitored and recorded on a specific Adverse Event (AE) log. | Day 1 | 
| Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain | The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain | Day 1 |