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

April 7, 2011 updated by: Seoul National University Hospital
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Cardiovascular Center, Seoul National University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adenosine Followed by Nicorandil
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).
EXPERIMENTAL: Nicorandil Followed by Adenosine
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional Flow Reserve at Maximal Hyperemia
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Maximal Hyperemia
Time Frame: 1 day
1 day
Changes in Heart Rate
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Boramae Hospital
Keimyung University Dongsan Medical Center
Inje University Ilsan Paik Hospital

Investigators

  • Study Chair: Bon-Kwon Koo, MD. PhD, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (ESTIMATE)

April 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1101-069-348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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