Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Mar 2011
Shorter than P25 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 8, 2011
April 1, 2011
6 months
April 1, 2011
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fractional Flow Reserve at Maximal Hyperemia
1 day
Secondary Outcomes (2)
Time to Maximal Hyperemia
1 day
Changes in Heart Rate
1 day
Study Arms (2)
Adenosine Followed by Nicorandil
EXPERIMENTALNicorandil Followed by Adenosine
EXPERIMENTALInterventions
Firstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg).
Firstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively).
Eligibility Criteria
You may qualify if:
- non -infarct related, patients with moderate coronary artery stenosis
- normal left ventricular ejection fraction on echocardiogram
You may not qualify if:
- infarct-related arteries or clinically unstable state
- collateral blood flow to the target vessel is shown
- atrioventricular block on electrocardiogram
- reduced left ventricular ejection fraction (\<50%) or left ventricular hypertrophy on echocardiogram
- contraindication of adenosine
- bronchial asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Seoul National University Boramae Hospitalcollaborator
- Inje University Ilsan Paik Hospitalcollaborator
- Keimyung University Dongsan Medical Centercollaborator
Study Sites (1)
Cardiovascular Center, Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Jang HJ, Koo BK, Lee HS, Park JB, Kim JH, Seo MK, Yang HM, Park KW, Nam CW, Doh JH, Kim HS. Safety and efficacy of a novel hyperaemic agent, intracoronary nicorandil, for invasive physiological assessments in the cardiac catheterization laboratory. Eur Heart J. 2013 Jul;34(27):2055-62. doi: 10.1093/eurheartj/eht040. Epub 2013 Feb 8.
PMID: 23396491DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bon-Kwon Koo, MD. PhD
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 8, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 8, 2011
Record last verified: 2011-04