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

Coronary Artery Disease Clinical Trial

Official title:

Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482169
• Other study ID #: 10012012
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2018
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing Measurement of Fractional Flow Reserve (FFR)	For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.	DAY 1
Secondary	Duration to Baseline Hyperemia After Aminophylline Injection	In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection	seconds