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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115308
• Other study ID #: Astellas CMR Tagging
• Status: Completed
• Phase: Phase 4
• Start date: September 3, 2014
• Est. completion date: March 23, 2018

Study information

• Verified date: August 2018
• Source: Aspire Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 23, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Saint Luke's Health System	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Timothy M. Bateman	Saint Luke's Cardiovascular Consultants, Saint Luke's Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Adverse Events	Adverse events were monitored and recorded on a specific Adverse Event (AE) log.	Day 1
Secondary	Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain	The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain	Day 1