Completed

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

What is being tested

Regadenoson central - peripheral

+ Adenosine

+ Regadenoson peripheral - central

Drug

Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 80 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Phase 3

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorLokien van Nunen

Last updated: November 13, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01809743

Principal SponsorLokien van Nunen

Last updated: November 13, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

Criteria

2 inclusion criteria required to participate

Age 18-80 years

Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery

14 exclusion criteria prevent from participating

Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)

History of severe COPD

Inability to provide informed consent

Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

First bolus regadenoson administered central, second bolus administered peripheral

Group II

Active Comparator

First bolus regadenoson administered peripheral, second bolus administered central

Group III

Active Comparator

First bolus regadenoson administered central, second bolus administered central

Group IV

Active Comparator

First bolus regadenoson administered peripheral, second bolus administered peripheral

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Catharina Hospital

Eindhoven, NetherlandsOpen Catharina Hospital in Google Maps

CompletedOne Study Center