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Completed

NCT Number: NCT02115308

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.

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Key information

Conditions

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

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regadenoson

Drug

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

Other names: Lexiscan

Primary outcomes

  1. RADIAL STRAIN

    Time frame: Day 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.

  2. CIRCUMFERENTIAL STRAIN

    Time frame: Day 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 outcomes

  1. Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain

    Time frame: Day 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?

  2. Adverse Events

    Time frame: Day 1

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

  3. Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain

    Time frame: Day 1

    The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain

Sponsors and collaborators

Lead sponsor

Timothy M. Bateman

Other

Collaborators

  • Saint Luke's Cardiovascular Consultants
  • Saint Luke's Health System

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2014
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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