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OpenTrials
Completed

NCT Number: NCT01070420

Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement

The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Center, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non -infarct related, patients with moderate coronary artery stenosis
  • normal ejection fraction on echocardiogram

Exclusion criteria

  • infarct-related arteries or clinically unstable state
  • collateral blood flow to the target vessel is shown
  • atrioventricular block on electrocardiogram
  • reduced ejection fraction(<50%) or left ventricular hypertrophy on echocardiography
  • contraindication of adenosine

Treatment and study plan

FFR via central venous line

Other

Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via Rt central femoral vein.

FFR via peripheral venous line

Other

Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via continuous peripheral vein.

Primary outcomes

  1. compare fractional flow reserve at maximal hyperemia

    Time frame: interval of 10 minutes

Secondary outcomes

  1. compare the time to maximal hyperemia and changes in heart rate

    Time frame: interval of 10 minutes

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Jul 18, 2011

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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