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Completed

NCT Number: NCT01482169

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FFR Measurement with IV Adenoscan® then with Regadenoson

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.

Other names: Adenoscan® vs Regadenoson

Primary outcomes

  1. Comparing Measurement of Fractional Flow Reserve (FFR)

    Time frame: DAY 1

    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.

Secondary outcomes

  1. Duration to Baseline Hyperemia After Aminophylline Injection

    Time frame: seconds

    In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • Astellas Pharma Global Development, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2011
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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