Phase
Condition
Atherosclerosis
Chest Pain
Vascular Diseases
Treatment
Regadenoson; Optison
Clinical Study ID
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female. Age ≥ 30 years.
Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplanemeasurement.
Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
Negative urine pregnancy test within 2 hours of ultrasound contrast administrationrequired of females of childbearing age unless post-menopausal or with evidence ofsurgical sterilization.
Be conscious and coherent, and able to communicate effectively with trial personnel.
Agreeable to undergo the additional stress test (which is being performed forresearch purposes only, not for clinical care) and coronary angiography (which isbeing performed for clinical care) based on the following clinical profile: Have atleast an intermediate likelihood of coronary disease based.
Good apical echo images with at least 50% of each coronary artery territory wellvisualized.
Exclusion
Exclusion Criteria:
Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
Pregnancy or lactation.
Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstableangina 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 stressimaging study associated with left ventricular cavity dilatation.
Early positive treadmill ECG within the first stage of the test.
History of > 1st degree heart block, sick sinus syndrome or high grade AV blockwithout a pacemaker.
Dipyridamole use within 30 hours of stress test, or consumption of methylxanthineswithin 12 hours, or use of sublingual nitroglycerin within two hours.
Participation in another investigational study within one month of this study.
Anyone in whom a stress test should not be performed prior to cardiaccatheterization.
Study Design
Study Description
Connect with a study center
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68105
United StatesSite Not Available

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