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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

Page last updated: February 07, 2013

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