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

NCT ID: NCT01482169

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adenoscan

Subjects will have the FFR Measurement with IV Adenoscan®

Group Type: ACTIVE_COMPARATOR

FFR Measurement with IV Adenoscan® then with Regadenoson

Intervention Type: DRUG

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.

Regadenoson

Subjects will have the FFR Measurement with IV Regadenoson

Group Type: EXPERIMENTAL

FFR Measurement with IV Adenoscan® then with Regadenoson

Intervention Type: DRUG

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.

Interventions

FFR Measurement with IV Adenoscan® then with Regadenoson

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.

Intervention Type: DRUG

Other Intervention Names

Adenoscan® vs Regadenoson

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: collaborator

Ochsner Health System

OTHER

Sponsor Role: lead

Responsible Party

Robert Bober, M.D.

Director of Nuclear Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Bober, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Medical Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

10012012

Identifier Type: -

Identifier Source: org_study_id