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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01331902

Enrollment

200

Registered

2011-04-08

Start date

2011-03-31

Completion date

2011-09-30

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Ischemia

Keywords

Adenosine, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia

Brief summary

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

Interventions

OTHERMaximal 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).

OTHERMaximal 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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Fractional Flow Reserve at Maximal Hyperemia	1 day

Secondary

Measure	Time frame
Time to Maximal Hyperemia	1 day
Changes in Heart Rate	1 day

Countries

South Korea

Contacts

Primary ContactHo-Jun Jang, MD

wingal@naver.com82-2-2072-3757

Backup ContactBon-Kwan Koo, MD.PhD

bkkoo@snu.ac.kr82-2-2072-2062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026