Regadenoson R-T Perfusion Imaging Trial

NCT ID: NCT00837369

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-07
• Study Completion Date: 2011-12-01

Brief Summary

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.

Detailed Description

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

Conditions

Coronary Artery Disease; Myocardial Perfusion Abnormalities

Keywords

Stress echocardiography; SPECT; Myocardial perfusion imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1 Real time perfusion (RTPE) imaging following Regadenoson

RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.

Group Type: EXPERIMENTAL

Regadenoson

Intervention Type: DRUG

400ug IV bolus injection, single dosage

Interventions

Regadenoson

400ug IV bolus injection, single dosage

Intervention Type: DRUG

Other Intervention Names

Definity (Lantheus Medical Imaging); Lipid encapsulated microbubbles

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medicial Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0566-08-FB

Identifier Type: -

Identifier Source: org_study_id