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Regadenoson and Adenosine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lokien van Nunen, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01809743
First received: December 18, 2012
Last updated: November 11, 2013
Last verified: November 2013

December 18, 2012
November 11, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01809743 on ClinicalTrials.gov Archive Site
time intervals of maximum hyperemia [ Time Frame: participants will be followed up during hospital stay, an expected average of 1 day ] [ Designated as safety issue: No ]
To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
Same as current
Not Provided
Not Provided
 
Regadenoson and Adenosine
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • 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).
  • 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).
  • 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: 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).
  • Drug: Adenosine
    Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
  • Active Comparator: Regadenoson central - peripheral
    First bolus regadenoson administered central, second bolus administered peripheral
    Interventions:
    • Drug: Regadenoson central - peripheral
    • Drug: Adenosine
  • Active Comparator: Regadenoson peripheral - central
    First bolus regadenoson administered peripheral, second bolus administered central
    Interventions:
    • Drug: Regadenoson peripheral - central
    • Drug: Adenosine
  • Active Comparator: Regadenoson central - central
    First bolus regadenoson administered central, second bolus administered central
    Interventions:
    • Drug: Regadenoson central -central
    • Drug: Adenosine
  • Active Comparator: Regadenoson peripheral - peripheral
    First bolus regadenoson administered peripheral, second bolus administered peripheral
    Interventions:
    • Drug: Regadenoson peripheral - peripheral
    • Drug: Adenosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2013
October 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01809743
NL42049.060.12
No
Lokien van Nunen, Catharina Ziekenhuis Eindhoven
Lokien van Nunen
Not Provided
Principal Investigator: Nico H.J. Pijls, MD, PhD Catharina Hospital Eindhoven
Study Director: Lokien X van Nunen, MD Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP