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

Tracking Information

First Received Date ^ICMJE

April 1, 2011

Last Updated Date

April 7, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01331902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease
Myocardial Ischemia

Intervention ^ICMJE

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).

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

September 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01331902

Other Study ID Numbers ^ICMJE

H-1101-069-348

Has Data Monitoring Committee

Yes

Responsible Party

Bon- Kwon Koo / prof, Cardiovascular Center, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Seoul National University Boramae Hospital
Inje University
Keimyung University Dongsan Medical Center

Investigators ^ICMJE

Study Chair:

Bon-Kwon Koo, MD. PhD

Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

April 2011

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

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