NCT01809743

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3 coronary-artery-disease

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

December 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

December 18, 2012

Last Update Submit

November 11, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseRegadenosonAdenosineMaximal hyperemiaFractional flow reserveFFR

Outcome Measures

Primary Outcomes (1)

  • the accuracy of Regadenoson to induce maximal and steady state hyperemia

    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 Outcomes (1)

  • time intervals of maximum hyperemia

    participants will be followed up during hospital stay, an expected average of 1 day

Study Arms (4)

Regadenoson central - peripheral

ACTIVE COMPARATOR

First bolus regadenoson administered central, second bolus administered peripheral

Drug: Regadenoson central - peripheralDrug: Adenosine

Regadenoson peripheral - central

ACTIVE COMPARATOR

First bolus regadenoson administered peripheral, second bolus administered central

Drug: Regadenoson peripheral - centralDrug: Adenosine

Regadenoson central - central

ACTIVE COMPARATOR

First bolus regadenoson administered central, second bolus administered central

Drug: Regadenoson central -centralDrug: Adenosine

Regadenoson peripheral - peripheral

ACTIVE COMPARATOR

First bolus regadenoson administered peripheral, second bolus administered peripheral

Drug: Regadenoson peripheral - peripheralDrug: Adenosine

Interventions

Regadenoson central -centralDRUG

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).

Regadenoson central - central
Regadenoson peripheral - peripheralDRUG

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).

Regadenoson peripheral - peripheral
Regadenoson central - peripheralDRUG

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).

Regadenoson central - peripheral
Regadenoson peripheral - centralDRUG

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).

Regadenoson peripheral - central
AdenosineDRUG

Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.

Regadenoson central - centralRegadenoson central - peripheralRegadenoson peripheral - centralRegadenoson peripheral - peripheral

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (1)

  • van Nunen LX, Lenders GD, Schampaert S, van 't Veer M, Wijnbergen I, Brueren GR, Tonino PA, Pijls NH. Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperaemia in fractional flow reserve measurement. EuroIntervention. 2015 Dec;11(8):905-13. doi: 10.4244/EIJY14M08_10.

    PMID: 25136887DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Nico H.J. Pijls, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Lokien X van Nunen, MD

    Catharina Ziekenhuis Eindhoven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 18, 2012

First Posted

March 13, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

NL(1)