Regadenoson and Adenosine

November 11, 2013 updated by: Lokien van Nunen

Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve

The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-80 years
  • Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery

Exclusion Criteria:

  • Severe aortic valve stenosis
  • History of severe COPD
  • Syncope or bradycardia (less than 50 beats/min)
  • Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
  • Severe hypotension (RR <90 mmHg)
  • Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic
  • Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)
  • Previous coronary bypass surgery
  • Recent ST elevation myocardial infarction (<5 days)
  • Recent non-ST elevation myocardial infarction (<5 days) if the peak CK is >1000 IU
  • Inability to provide informed consent
  • Pregnancy
  • Use of methylxanthines (in the last 12 hours)
  • Use of Dipyridamol (in the last 48 hours)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Regadenoson central - peripheral
First bolus regadenoson administered central, second bolus administered peripheral
Drug: Regadenoson central - peripheral
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
Drug: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
ACTIVE_COMPARATOR: Regadenoson peripheral - central
First bolus regadenoson administered peripheral, second bolus administered central
Drug: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Drug: Regadenoson peripheral - central
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
ACTIVE_COMPARATOR: Regadenoson central - central
First bolus regadenoson administered central, second bolus administered central
Drug: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Drug: Regadenoson central -central
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
ACTIVE_COMPARATOR: Regadenoson peripheral - peripheral
First bolus regadenoson administered peripheral, second bolus administered peripheral
Drug: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Drug: Regadenoson peripheral - peripheral
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy of Regadenoson to induce maximal and steady state hyperemia
Time Frame: participants will be followed up during hospital stay, an expected average of 1 day
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard).
participants will be followed up during hospital stay, an expected average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time intervals of maximum hyperemia
Time Frame: participants will be followed up during hospital stay, an expected average of 1 day
To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
participants will be followed up during hospital stay, an expected average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lokien van Nunen

Investigators

  • Principal Investigator: Nico H.J. Pijls, MD, PhD, Catharina Ziekenhuis Eindhoven
  • Study Director: Lokien X van Nunen, MD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

March 11, 2013

First Posted (ESTIMATE)

March 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL42049.060.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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