Regadenoson R-T Perfusion Imaging Trial

NCT00837369 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 0566-08-FB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Myocardial Perfusion Abnormalities

Keywords

Stress echocardiography; SPECT; Myocardial perfusion imaging

Outcome Measures

Primary Outcomes (1)

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

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

  1 hour observation post perfusion

Study Arms (1)

1 Real time perfusion (RTPE) imaging following Regadenoson

EXPERIMENTAL

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.

Drug: Regadenoson

Interventions

Regadenoson DRUG

400ug IV bolus injection, single dosage

Also known as: Definity (Lantheus Medical Imaging), Lipid encapsulated microbubbles

1 Real time perfusion (RTPE) imaging following Regadenoson

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Mayo Clinic: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medicial Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson; perflutren

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thomas Porter
• Organization: University of Nebraska Medical Center

trporter@unmc.edu

402-559-5151

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 5, 2009
• Study Start: April 7, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 27, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Locations

US (2)