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Regadenoson and Adenosine

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Regadenoson central -central
Regadenoson peripheral - peripheral
Regadenoson central - peripheral
Regadenoson peripheral - central
Adenosine
Sponsored by
Lokien van Nunen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Catharina Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Regadenoson central - peripheral

Regadenoson peripheral - central

Regadenoson central - central

Regadenoson peripheral - peripheral

Arm Description

First bolus regadenoson administered central, second bolus administered peripheral

First bolus regadenoson administered peripheral, second bolus administered central

First bolus regadenoson administered central, second bolus administered central

First bolus regadenoson administered peripheral, second bolus administered peripheral

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

time intervals of maximum hyperemia
To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.

Full Information

First Posted
December 18, 2012
Last Updated
November 11, 2013
Sponsor
Lokien van Nunen
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1. Study Identification

Unique Protocol Identification Number
NCT01809743
Brief Title
Regadenoson and Adenosine
Official Title
Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lokien van Nunen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regadenoson central - peripheral
Arm Type
Active Comparator
Arm Description
First bolus regadenoson administered central, second bolus administered peripheral
Arm Title
Regadenoson peripheral - central
Arm Type
Active Comparator
Arm Description
First bolus regadenoson administered peripheral, second bolus administered central
Arm Title
Regadenoson central - central
Arm Type
Active Comparator
Arm Description
First bolus regadenoson administered central, second bolus administered central
Arm Title
Regadenoson peripheral - peripheral
Arm Type
Active Comparator
Arm Description
First bolus regadenoson administered peripheral, second bolus administered peripheral
Intervention Type
Drug
Intervention Name(s)
Regadenoson central -central
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Regadenoson peripheral - peripheral
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Regadenoson central - peripheral
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Regadenoson peripheral - central
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Primary Outcome Measure Information:
Title
the accuracy of Regadenoson to induce maximal and steady state hyperemia
Description
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).
Time Frame
participants will be followed up during hospital stay, an expected average of 1 day
Secondary Outcome Measure Information:
Title
time intervals of maximum hyperemia
Description
To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
Time Frame
participants will be followed up during hospital stay, an expected average of 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nico H.J. Pijls, MD, PhD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lokien X van Nunen, MD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Study Director
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25136887
Citation
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.
Results Reference
derived

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Regadenoson and Adenosine

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