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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Regadenoson
Sponsored by
Timothy M. Bateman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Luke's Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Regadenoson

Arm Description

Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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?
Adverse Events
Adverse events were monitored and recorded on a specific Adverse Event (AE) log.
Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain
The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain

Full Information

First Posted
April 1, 2014
Last Updated
August 21, 2018
Sponsor
Timothy M. Bateman
Collaborators
Saint Luke's Health System, Saint Luke's Cardiovascular Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT02115308
Brief Title
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Official Title
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2014 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy M. Bateman
Collaborators
Saint Luke's Health System, Saint Luke's Cardiovascular Consultants

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regadenoson
Arm Type
Other
Arm Description
Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Lexiscan
Intervention Description
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.
Primary Outcome Measure Information:
Title
RADIAL STRAIN
Description
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.
Time Frame
Day 1
Title
CIRCUMFERENTIAL STRAIN
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain
Description
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?
Time Frame
Day 1
Title
Adverse Events
Description
Adverse events were monitored and recorded on a specific Adverse Event (AE) log.
Time Frame
Day 1
Title
Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain
Description
The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Bateman, MD
Organizational Affiliation
Aspire Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

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

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