NCT01809743 - Regadenoson and Adenosine | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

Regadenoson central -centralDRUG

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).

Regadenoson peripheral - peripheralDRUG

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).

Regadenoson central - peripheralDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Outcomes

Primary Outcomes

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).

Time frame: participants will be followed up during hospital stay, an expected average of 1 day

Secondary Outcomes

time intervals of maximum hyperemia

To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.

Time frame: participants will be followed up during hospital stay, an expected average of 1 day