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NCT01331902 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01331902
Other study ID # H-1101-069-348
Secondary ID
Status Recruiting
Phase Phase 4
First received April 1, 2011
Last updated April 7, 2011
Start date March 2011
Est. completion date September 2011

Study information
Verified date April 2011
Source Seoul National University Hospital
Contact Ho-Jun Jang, MD
Phone 82-2-2072-3757
Email wingal@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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).
• 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).

Locations
Country Name City State
Korea, Republic of Cardiovascular Center, Seoul National University Hospital Seoul

Sponsors (4)
Lead Sponsor Collaborator
Seoul National University Hospital Inje University, Keimyung University Dongsan Medical Center, Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fractional Flow Reserve at Maximal Hyperemia 1 day No
Secondary Time to Maximal Hyperemia 1 day No
Secondary Changes in Heart Rate 1 day No
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