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
Sponsored by
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
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
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 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
No
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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