Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Seoul National University Boramae Hospital
Inje University
Keimyung University Dongsan Medical Center
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01331902
First received: April 1, 2011
Last updated: April 7, 2011
Last verified: April 2011

April 1, 2011
April 7, 2011
March 2011
September 2011   (final data collection date for primary outcome measure)
Fractional Flow Reserve at Maximal Hyperemia [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01331902 on ClinicalTrials.gov Archive Site
  • Time to Maximal Hyperemia [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Changes in Heart Rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
Not Provided

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Other: Maximal Hyperemia with Adenosine Followed by Nicorandil
    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).
  • Other: Maximal Hyperemia with Nicorandil Followed by Adenosine
    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).
  • Experimental: Adenosine Followed by Nicorandil
    Intervention: Other: Maximal Hyperemia with Adenosine Followed by Nicorandil
  • Experimental: Nicorandil Followed by Adenosine
    Intervention: Other: Maximal Hyperemia with Nicorandil Followed by Adenosine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Ho-Jun Jang, MD 82-2-2072-3757 wingal@naver.com
Contact: Bon-Kwan Koo, MD.PhD 82-2-2072-2062 bkkoo@snu.ac.kr
Korea, Republic of
 
NCT01331902
H-1101-069-348
Yes
Bon- Kwon Koo / prof, Cardiovascular Center, Seoul National University Hospital
Seoul National University Hospital
  • Seoul National University Boramae Hospital
  • Inje University
  • Keimyung University Dongsan Medical Center
Study Chair: Bon-Kwon Koo, MD. PhD Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Seoul National University Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP