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Regadenoson R-T Perfusion Imaging Trial

Primary Purpose

Coronary Artery Disease, Myocardial Perfusion Abnormalities

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regadenoson
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Stress echocardiography, SPECT, Myocardial perfusion imaging

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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., 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 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.

Sites / Locations

  • Mayo Clinic
  • University of Nebraska Medicial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

more feasible and accurate way to detect significant coronary artery disease

Secondary Outcome Measures

Full Information

First Posted
February 3, 2009
Last Updated
July 19, 2012
Sponsor
University of Nebraska
Collaborators
Mayo Clinic, Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00837369
Brief Title
Regadenoson R-T Perfusion Imaging Trial
Official Title
Regadenoson Real Time Perfusion Imaging Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
Collaborators
Mayo Clinic, Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the A2A Receptor 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Perfusion Abnormalities
Keywords
Stress echocardiography, SPECT, Myocardial perfusion imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Definity (Lantheus Medical Imaging), Lipid encapsulated microbubbles
Intervention Description
400ug IV bolus injection, single dosage
Primary Outcome Measure Information:
Title
more feasible and accurate way to detect significant coronary artery disease
Time Frame
upon completion of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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., 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 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.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medicial Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

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