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

Phase 4UnknownNCT01331902

Seoul National University Hospital200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

200

Conditions

Coronary Artery Disease Myocardial Ischemia

Interventions

Maximal Hyperemia with Adenosine Followed by NicorandilOTHER

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).

Maximal Hyperemia with Nicorandil Followed by AdenosineOTHER

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

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular Center, Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Fractional Flow Reserve at Maximal Hyperemia

Time frame: 1 day

Secondary Outcomes

Time to Maximal Hyperemia

Time frame: 1 day

Changes in Heart Rate

Time frame: 1 day

Central Contacts

Ho-Jun Jang, MD

CONTACT

82-2-2072-3757 wingal@naver.com

Bon-Kwan Koo, MD.PhD

CONTACT

82-2-2072-2062 bkkoo@snu.ac.kr

Data from ClinicalTrials.gov

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