Regadenoson and Adenosine

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809743
• Other study ID #: NL42049.060.12
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2012
• Last updated: November 11, 2013
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Regadenoson 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).
• Regadenoson 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).
• Regadenoson 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).
• Regadenoson 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).
• Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Lokien van Nunen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No