Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2013-01-31
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regadenoson central - peripheral
First bolus regadenoson administered central, second bolus administered peripheral
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).
Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Regadenoson peripheral - central
First bolus regadenoson administered peripheral, second bolus administered central
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.
Regadenoson central - central
First bolus regadenoson administered central, second bolus administered central
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).
Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Regadenoson peripheral - peripheral
First bolus regadenoson administered peripheral, second bolus administered peripheral
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).
Adenosine
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lokien van Nunen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lokien van Nunen
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nico H.J. Pijls, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Lokien X van Nunen, MD
Role: STUDY_DIRECTOR
Catharina Ziekenhuis Eindhoven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van Nunen LX, Lenders GD, Schampaert S, van 't Veer M, Wijnbergen I, Brueren GR, Tonino PA, Pijls NH. Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperaemia in fractional flow reserve measurement. EuroIntervention. 2015 Dec;11(8):905-13. doi: 10.4244/EIJY14M08_10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL42049.060.12
Identifier Type: -
Identifier Source: org_study_id