Trial | NCT01809743  Report issue

Title

Regadenoson and Adenosine
Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    adenosine regadenoson ...

  • Study Participants

    100
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.
Study Started
Jan 31
2013
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Nov 13
2013
Estimate

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.

Regadenoson central - peripheral Active Comparator

First bolus regadenoson administered central, second bolus administered peripheral

Regadenoson peripheral - central Active Comparator

First bolus regadenoson administered peripheral, second bolus administered central

Regadenoson central - central Active Comparator

First bolus regadenoson administered central, second bolus administered central

Regadenoson peripheral - peripheral Active Comparator

First bolus regadenoson administered peripheral, second bolus administered peripheral

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)
No Results Posted