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

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

FFR via central venous line

FFR via peripheral venous line

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Adenosine, Fractional flow reserve, Hyperemia, Fractional Flow Reserve, Myocardial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiovascular Center, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FFR via central venous line

FFR via peripheral vein

Arm Description

Outcomes

Primary Outcome Measures

compare fractional flow reserve at maximal hyperemia

Secondary Outcome Measures

compare the time to maximal hyperemia and changes in heart rate

Full Information

NCT ID

NCT01070420

First Posted

January 10, 2010

Last Updated

July 15, 2011

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01070420

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Myocardial Ischemia

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FFR via central venous line

Arm Type

Active Comparator

Arm Title

FFR via peripheral vein

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

FFR via central venous line

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

FFR via peripheral venous line

Intervention Description

Primary Outcome Measure Information:

Title

compare fractional flow reserve at maximal hyperemia

Time Frame

interval of 10 minutes

Secondary Outcome Measure Information:

Title

compare the time to maximal hyperemia and changes in heart rate

Time Frame

interval of 10 minutes

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bon- Kwon Koo, MD, PhD

Organizational Affiliation

Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Cardiovascular Center, Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22693347

Citation

Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Her SH, Hur SH, Park JS, Kim MK, Choi YS, Kim HS, Cho JH, Lee SG, Park YW, Jeong MH, Lee BK, Lee NH, Lim DS, Yoon J, Seung KB, Shin WY, Rha SW, Kim KS, Tahk SJ, Park BE, Ahn T, Yang JY, Jeong YS, Rhew JH, Park SJ; IRIS-DES Investigators. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study. Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.

Results Reference

derived

PubMed Identifier

22647519

Citation

Seo MK, Koo BK, Kim JH, Shin DH, Yang HM, Park KW, Lee HY, Kang HJ, Kim HS, Oh BH, Park YB. Comparison of hyperemic efficacy between central and peripheral venous adenosine infusion for fractional flow reserve measurement. Circ Cardiovasc Interv. 2012 Jun;5(3):401-5. doi: 10.1161/CIRCINTERVENTIONS.111.965392. Epub 2012 May 29.

Results Reference

derived

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

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