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

Phase 4
Completed
Conditions
Coronary Artery Disease
Interventions
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
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RegadenosonRegadenosonRegadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
Primary Outcome Measures
NameTimeMethod
RADIAL STRAINDay 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 STRAINDay 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
NameTimeMethod
Late Gadolinium Enhancement (LGE) and RADIAL Myocardial StrainDay 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 EventsDay 1

Adverse events were monitored and recorded on a specific Adverse Event (AE) log.

Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial StrainDay 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

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