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

Phase 4

• Conditions: Coronary Artery Disease; Myocardial Ischemia
• Interventions: Other: Maximal Hyperemia with Adenosine Followed by Nicorandil; Other: Maximal Hyperemia with Nicorandil Followed by Adenosine

• Registration Number: NCT01331902
• Lead Sponsor: Seoul National University Hospital

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 available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-07
• Last Update Submitted: 2011-04-07
• Study First Posted: 2011-04-08
• Last Update Posted: 2011-04-08
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adenosine Followed by Nicorandil	Maximal Hyperemia with Adenosine Followed by Nicorandil	-
Nicorandil Followed by Adenosine	Maximal Hyperemia with Nicorandil Followed by Adenosine	-

Primary Outcome Measures

Name	Time	Method
Fractional Flow Reserve at Maximal Hyperemia	1 day

Secondary Outcome Measures

Name	Time	Method
Time to Maximal Hyperemia	1 day
Changes in Heart Rate	1 day

Trial Locations

Locations (1)

Cardiovascular Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of