Status:
COMPLETED
Regadenoson and Adenosine
Lead Sponsor:
Lokien van Nunen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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. (ade...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01809743
Start Date
January 1 2013
End Date
October 1 2013
Last Update
November 13 2013
Active Locations (1)
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1
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ