Regadenoson and Adenosine

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Regadenoson central -central; Drug: Regadenoson central - peripheral; Drug: Regadenoson peripheral - central; Drug: Regadenoson peripheral - peripheral; Drug: Adenosine

• Registration Number: NCT01809743
• Lead Sponsor: Lokien van Nunen

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 available

Study Timeline

• Study First Submitted: 2012-12-18
• Study Start: 2013-01
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regadenoson central - central	Regadenoson central -central	First bolus regadenoson administered central, second bolus administered central
Regadenoson central - peripheral	Regadenoson central - peripheral	First bolus regadenoson administered central, second bolus administered peripheral
Regadenoson peripheral - central	Regadenoson peripheral - central	First bolus regadenoson administered peripheral, second bolus administered central
Regadenoson peripheral - central	Adenosine	First bolus regadenoson administered peripheral, second bolus administered central
Regadenoson peripheral - peripheral	Regadenoson peripheral - peripheral	First bolus regadenoson administered peripheral, second bolus administered peripheral
Regadenoson central - peripheral	Adenosine	First bolus regadenoson administered central, second bolus administered peripheral
Regadenoson central - central	Adenosine	First bolus regadenoson administered central, second bolus administered central
Regadenoson peripheral - peripheral	Adenosine	First bolus regadenoson administered peripheral, second bolus administered peripheral

Primary Outcome Measures

Name	Time	Method
the accuracy of Regadenoson to induce maximal and steady state hyperemia	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).

Secondary Outcome Measures

Name	Time	Method
time intervals of maximum hyperemia	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.

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands