Conditions: Coronary Artery Disease
Keywords: Left heart catheterization Fractional flow reserve Adenoscan® Regadenoson
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: Subjects will have the FFR Measurement with IV Adenoscan® arm 2: Subjects will have the FFR Measurement with IV Regadenoson

Interventions: intervention 1: FFR Measurement with IV Adenoscan® then with Regadenoson
Intervention descriptions: intervention 1: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.

Protocol document: