Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR
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.
Interventions
DRUGRegadenoson 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).
DRUGRegadenoson 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).
DRUGRegadenoson 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).
DRUGRegadenoson 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).
DRUGAdenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Sponsors
Lokien van Nunen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed