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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ochsner Health System
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Robert Bober, M.D., Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01482169
First received: November 15, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Coronary Artery Disease
Drug: FFR Measurement with IV Adenoscan® then with Regadenoson

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • Comparing measurement of Fractional Flow Reserve (FFR) [ Time Frame: DAY 1 ] [ Designated as safety issue: No ]
    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. To assist in the vital signs returning to normal, the subject will be administered aminophylline.


Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving both meds for comparison
Subjects will have the FFR procedure twice, first with Adenoscan® and then Regadenoson.
Drug: FFR Measurement with IV Adenoscan® then with Regadenoson
Testing will be completed during a Left Heart Catheterization (LHC) procedure. The first 48 eligible patients enrolled in the study 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. In the event of a serious adverse reaction to adenosine or regadenoson (heart block, bronchospasm, arrhythmias) the protocol will be suspended. Patients who react to either medication will be supported conservatively under close scrutiny. Any adverse reactions will be recorded and reported.
Other Name: Adenoscan® vs Regadenoson

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482169

Contacts
Contact: Christopher Wright, RN chrwright@ochsner.org

Locations
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Christopher Wright, RN       chrwright@ochsner.org   
Principal Investigator: Robert Bober, MD         
Sub-Investigator: Christopher White, MD         
Sub-Investigator: John Lee, MD         
Sponsors and Collaborators
Ochsner Health System
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: Robert Bober, MD Ochsner Health System
  More Information

No publications provided

Responsible Party: Robert Bober, M.D., Director of Nuclear Cardiology, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01482169     History of Changes
Other Study ID Numbers: 10012012
Study First Received: November 15, 2011
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ochsner Health System:
Left heart catheterization
Fractional flow reserve
Adenoscan®
Regadenoson

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014