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Regadenoson and Adenosine

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ClinicalTrials.gov Identifier: NCT01809743
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Lokien van Nunen, Catharina Ziekenhuis Eindhoven

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE March 13, 2013
Last Update Posted Date November 13, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01809743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regadenoson and Adenosine
Official Title  ICMJE Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809743
Other Study ID Numbers  ICMJE NL42049.060.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lokien van Nunen, Catharina Ziekenhuis Eindhoven
Study Sponsor  ICMJE Lokien van Nunen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nico H.J. Pijls, MD, PhD Catharina Ziekenhuis Eindhoven
Study Director: Lokien X van Nunen, MD Catharina Ziekenhuis Eindhoven
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date November 2013

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