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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
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Myocardial Ischemia
 Other: Maximal Hyperemia with Adenosine Followed by Nicorandil
Other: Maximal Hyperemia with Nicorandil Followed by Adenosine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Adenosine
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Fractional Flow Reserve at Maximal Hyperemia [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adenosine Followed by Nicorandil 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).
Experimental: Nicorandil Followed by Adenosine 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331902

Contacts
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

Locations
Korea, Republic of
Cardiovascular Center, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ho-Jun Jang, MD     82-2-2072-3757     wingal@naver.com    
Contact: Bon-Kwon Koo, MD.PhD     82-2-2072-2062     bkkoo@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Boramae Hospital
Inje University
Keimyung University Dongsan Medical Center
Investigators
Study Chair: Bon-Kwon Koo, MD. PhD Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Bon- Kwon Koo / prof, Cardiovascular Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01331902     History of Changes
Other Study ID Numbers: H-1101-069-348
Study First Received: April 1, 2011
Last Updated: April 7, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Adenosine
Nicorandil
Fractional Flow Reserve
Maximal Hyperemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Adenosine
Nicorandil
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Antihypertensive Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013