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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Regadenoson

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Timothy M. Bateman
• Collaborators: Saint Luke's Health System; Saint Luke's Cardiovascular Consultants
• Investigators: Principal Investigator: Timothy M Bateman, MD, Aspire Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): January 16, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: Astellas CMR Tagging