NCT01482169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

November 15, 2011

Results QC Date

April 26, 2017

Last Update Submit

May 9, 2018

Conditions

Coronary Artery Disease

Keywords

Left heart catheterizationFractional flow reserveAdenoscan®Regadenoson

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Duration to Baseline Hyperemia After Aminophylline Injection

    seconds

Study Arms (2)

Adenoscan

ACTIVE COMPARATOR

Subjects will have the FFR Measurement with IV Adenoscan®

Drug: FFR Measurement with IV Adenoscan® then with Regadenoson

Regadenoson

EXPERIMENTAL

Subjects will have the FFR Measurement with IV Regadenoson

Drug: FFR Measurement with IV Adenoscan® then with Regadenoson

Interventions

FFR Measurement with IV Adenoscan® then with RegadenosonDRUG

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.

Also known as: Adenoscan® vs Regadenoson
AdenoscanRegadenoson

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective left heart catheterization
  • Age ≥ 18 years (female not of child bearing potential)
  • Able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Dr. Robert Bober
Organization
Ochsner Clinic Foundation
rbober@ochsner.org
504-842-4135

Study Officials

  • Robert Bober, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nuclear Cardiology

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 30, 2011

Study Start

March 1, 2012

Primary Completion

May 1, 2014

Study Completion

September 1, 2014

Last Updated

May 11, 2018

Results First Posted

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)