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Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Maximal Hyperemia with Adenosine Followed by Nicorandil
Maximal Hyperemia with Nicorandil Followed by Adenosine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Adenosine, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia

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 left ventricular 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 left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram
  • contraindication of adenosine
  • bronchial asthma

Sites / Locations

  • Cardiovascular Center, Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adenosine Followed by Nicorandil

Nicorandil Followed by Adenosine

Arm Description

Outcomes

Primary Outcome Measures

Fractional Flow Reserve at Maximal Hyperemia

Secondary Outcome Measures

Time to Maximal Hyperemia
Changes in Heart Rate

Full Information

First Posted
April 1, 2011
Last Updated
April 7, 2011
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Boramae Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01331902
Brief Title
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Boramae Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.

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, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adenosine Followed by Nicorandil
Arm Type
Experimental
Arm Title
Nicorandil Followed by Adenosine
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Maximal Hyperemia with Adenosine Followed by Nicorandil
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Maximal Hyperemia with Nicorandil Followed by Adenosine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fractional Flow Reserve at Maximal Hyperemia
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time to Maximal Hyperemia
Time Frame
1 day
Title
Changes in Heart Rate
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non -infarct related, patients with moderate coronary artery stenosis normal left ventricular 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 left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram contraindication of adenosine bronchial asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho-Jun Jang, MD
Phone
82-2-2072-3757
Email
wingal@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bon-Kwan Koo, MD.PhD
Phone
82-2-2072-2062
Email
bkkoo@snu.ac.kr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Jun Jang, MD
Phone
82-2-2072-3757
Email
wingal@naver.com
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD.PhD
Phone
82-2-2072-2062
Email
bkkoo@snu.ac.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
23396491
Citation
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.
Results Reference
derived

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Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

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