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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070420
• Other study ID #: D-0910-002-062
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2010
• Last updated: July 15, 2011
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• FFR 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.
• FFR 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.

Locations

Country	Name	City	State
Korea, Republic of	Cardiovascular Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare fractional flow reserve at maximal hyperemia		interval of 10 minutes	No
Secondary	compare the time to maximal hyperemia and changes in heart rate		interval of 10 minutes	Yes