Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
Information source: Ochsner Health System
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: FFR Measurement with IV Adenoscan® then with Regadenoson (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ochsner Health System Official(s) and/or principal investigator(s):
Robert Bober, MD, Principal Investigator, Affiliation: Ochsner Health System
Overall contact:
Christopher Wright, RN, Email: chrwright@ochsner.org
Summary
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to
intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
Clinical Details
Official title: Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Comparing measurement of Fractional Flow Reserve (FFR)
Detailed description:
This is a prospective open label, single center pilot trial that will evaluate regadenoson
compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty
eight subjects will be enrolled and get Adenoscan® administered via IV followed by
Regadenoson IV.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing elective left heart catheterization
- Age ≥ 18 years (female not of child bearing potential)
- Able to provide written informed consent
Exclusion Criteria:
- Contraindications to administration of either Adenoscan® or Regadenoson
- High degree AV block, sick sinus syndrome without a functioning pacemaker
- Symptomatic bradycardia
- Recent STEMI (< 5 days)
- Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
- Dipyridamole use within 24 hours
- Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or
aminophylline
- Known severe bronchoconstrictive lung disease
Locations and Contacts
Christopher Wright, RN, Email: chrwright@ochsner.org
Ochsner Medical Center, New Orleans, Louisiana 70121, United States; Recruiting
Christopher Wright, RN, Email: chrwright@ochsner.org
Robert Bober, MD, Principal Investigator
Christopher White, MD, Sub-Investigator
John Lee, MD, Sub-Investigator
Additional Information
Starting date: March 2012
Last updated: March 28, 2012
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