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Completed

NCT Number: NCT00837369

Regadenoson R-T Perfusion Imaging Trial

To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female. Age ≥30 years.
  • Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplane measurement.
  • Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
  • Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.
  • Be conscious and coherent, and able to communicate effectively with trial personnel.
  • Agreeable to undergo the additional stress test and coronary angiography
  • Have at least an intermediate likelihood of coronary disease based on the following clinical profile
  • Good apical echo images with at least 50% of each coronary artery territory well visualized.

Exclusion criteria

  • Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
  • Pregnancy or lactation.
  • Complicated hemodynamic instability (i.e., New York Heart Association (NYHA) Class IV heart failure, unstable angina at rest despite medical therapy).
  • Life expectancy of less than two months or terminally ill.
  • Congestive (idiopathic) or hypertrophic cardiomyopathy.
  • Known left main disease.
  • Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.
  • Resting Left Ventricular Ejection Fraction < 40%
  • Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.
  • Early positive treadmill EKG within the first stage of the test.
  • History of >1st degree heart block, sick sinus syndrome or high grade atrioventricular (AV) block without a pacemaker.
  • Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.
  • Participation In another investigational study within one month of this study.

Treatment and study plan

Regadenoson

Drug

400ug IV bolus injection, single dosage

Other names: Definity (Lantheus Medical Imaging), Lipid encapsulated microbubbles

Primary outcomes

  1. Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress

    Time frame: 1 hour observation post perfusion

    Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Astellas Pharma Inc
  • Mayo Clinic

Registry information

Official study title

Regadenoson Real Time Perfusion Imaging Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2009
Registry last updated
Dec 27, 2024

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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