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Completed

NCT Number: NCT01809743

Regadenoson and Adenosine

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regadenoson central -central

Drug

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

Drug

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

Drug

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

Drug

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

Drug

Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.

Primary outcomes

  1. the accuracy of Regadenoson to induce maximal and steady state hyperemia

    Time frame: 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 outcomes

  1. time intervals of maximum hyperemia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lokien van Nunen

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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