Regadenoson and Adenosine

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Regadenoson central -central
* Drug: Regadenoson peripheral - peripheral
* Drug: Regadenoson central - peripheral
* Drug: Regadenoson peripheral - central
* Drug: Adenosine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regadenoson central - peripheral<br>First bolus regadenoson administered central, second bolus administered peripheral | Drug: Regadenoson central - peripheral<br>* 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).<br>Drug: Adenosine<br>* Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.<br>|
| Active Comparator: Regadenoson peripheral - central<br>First bolus regadenoson administered peripheral, second bolus administered central | Drug: Regadenoson peripheral - central<br>* 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).<br>Drug: Adenosine<br>* Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.<br>|
| Active Comparator: Regadenoson central - central<br>First bolus regadenoson administered central, second bolus administered central | Drug: Regadenoson central -central<br>* 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).<br>Drug: Adenosine<br>* Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.<br>|
| Active Comparator: Regadenoson peripheral - peripheral<br>First bolus regadenoson administered peripheral, second bolus administered peripheral | Drug: Regadenoson peripheral - peripheral<br>* 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).<br>Drug: Adenosine<br>* Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | participants will be followed up during hospital stay, an expected average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time intervals of maximum hyperemia | To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson. | participants will be followed up during hospital stay, an expected average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR