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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Coronary Artery Disease Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Adenosine Followed by Nicorandil

Group Type EXPERIMENTAL

Maximal Hyperemia with Adenosine Followed by Nicorandil

Intervention Type OTHER

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).

Nicorandil Followed by Adenosine

Group Type EXPERIMENTAL

Maximal Hyperemia with Nicorandil Followed by Adenosine

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No