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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: FFR Measurement with IV Adenoscan® then with Regadenoson


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adenoscan<br>Subjects will have the FFR Measurement with IV Adenoscan® | Drug: FFR Measurement with IV Adenoscan® then with Regadenoson<br>* 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.<br>* Other names: Adenoscan® vs Regadenoson;|
| Experimental: Regadenoson<br>Subjects will have the FFR Measurement with IV Regadenoson | Drug: FFR Measurement with IV Adenoscan® then with Regadenoson<br>* 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.<br>* Other names: Adenoscan® vs Regadenoson;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration to Baseline Hyperemia After Aminophylline Injection | In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection | seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson