Regadenoson and Adenosine

Lokien van Nunen

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Regadenoson peripheral - peripheral; Drug: Adenosine; Drug: Regadenoson central - peripheral; Drug: Regadenoson peripheral - central; Drug: Regadenoson central -central

Study type: Interventional

Funder types: Other

Identifiers

NCT01809743

NL42049.060.12

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Regadenoson central - peripheral

Active Comparator group

Description:

First bolus regadenoson administered central, second bolus administered peripheral

Treatment:

Drug: Adenosine

Drug: Regadenoson central - peripheral

Regadenoson peripheral - central

Active Comparator group

Description:

First bolus regadenoson administered peripheral, second bolus administered central

Treatment:

Drug: Adenosine

Drug: Regadenoson peripheral - central

Regadenoson central - central

Active Comparator group

Description:

First bolus regadenoson administered central, second bolus administered central

Treatment:

Drug: Adenosine

Drug: Regadenoson central -central

Regadenoson peripheral - peripheral

Active Comparator group

Description:

First bolus regadenoson administered peripheral, second bolus administered peripheral

Treatment:

Drug: Regadenoson peripheral - peripheral

Drug: Adenosine