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

NCT02115308 | Completed Phase 4 Results

• 1 other identifier: Astellas CMR Tagging
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain

  Day 1

• Adverse Events

  Day 1

• Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain

  Day 1

Study Arms (1)

Regadenoson

OTHER

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

Drug: Regadenoson

Interventions

Regadenoson DRUG

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.

Also known as: Lexiscan

Regadenoson

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy M. Bateman: lead
• Saint Luke's Health System: collaborator
• Saint Luke's Cardiovascular Consultants: collaborator

Study Sites (1)

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Reported strain is not adjusted for myocardial mass.

Results Point of Contact

• Title: Joseph Soltys, PhD
• Organization: Cardiovascular Imaging Technologies, LLC

jsoltys@cvit.com

816-531-2842

Study Officials

• Timothy M Bateman, MD

  Aspire Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 16, 2014
• Study Start: September 3, 2014
• Primary Completion: January 16, 2018
• Study Completion: March 23, 2018
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-08

Locations

US (1)