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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Regadenoson central -central
Drug: Regadenoson peripheral - peripheral
Drug: Regadenoson central - peripheral
Drug: Regadenoson peripheral - central
Drug: Adenosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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 - central
First bolus regadenoson administered central, second bolus administered central
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: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Active Comparator: Regadenoson peripheral - peripheral
First bolus regadenoson administered peripheral, second bolus administered peripheral
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: Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809743

Locations
Netherlands
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Lokien van Nunen
Investigators
Principal Investigator: Nico H.J. Pijls, MD, PhD Catharina Hospital Eindhoven
Study Director: Lokien X van Nunen, MD Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: Lokien van Nunen, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01809743     History of Changes
Other Study ID Numbers: NL42049.060.12
Study First Received: December 18, 2012
Last Updated: November 11, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Coronary artery disease
Regadenoson
Adenosine
Maximal hyperemia
Fractional flow reserve
FFR

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014