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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070420
Enrollment
66
Registered
2010-02-18
Start date
2009-12-31
Completion date
2011-05-31
Last updated
2011-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Ischemia

Keywords

Adenosine, Fractional flow reserve, Hyperemia, Fractional Flow Reserve, Myocardial

Brief summary

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.

Interventions

OTHERFFR via central venous line

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.

OTHERFFR via peripheral venous line

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
compare fractional flow reserve at maximal hyperemiainterval of 10 minutes

Secondary

MeasureTime frame
compare the time to maximal hyperemia and changes in heart rateinterval of 10 minutes

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026