Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Ochsner Health System

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: FFR Measurement with IV Adenoscan® then with Regadenoson

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01482169

10012012

Details and patient eligibility

About

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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