Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement

July 15, 2011 updated by: Seoul National University Hospital
The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

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
        • Cardiovascular Center, Seoul National University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • non -infarct related, patients with moderate coronary artery stenosis
  • normal 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 ejection fraction(<50%) or left ventricular hypertrophy on echocardiography
  • contraindication of adenosine

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FFR via central venous line
Other: FFR via central venous line
Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via Rt central femoral vein.
Experimental: FFR via peripheral vein
Other: FFR via peripheral venous line
Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via continuous peripheral vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare fractional flow reserve at maximal hyperemia
Time Frame: interval of 10 minutes
interval of 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
compare the time to maximal hyperemia and changes in heart rate
Time Frame: interval of 10 minutes
interval of 10 minutes

Collaborators and Investigators

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

Sponsor

Seoul National University 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

December 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 10, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

July 18, 2011

Last Update Submitted That Met QC Criteria

July 15, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-0910-002-062

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.

Clinical Trials on Myocardial Ischemia

Clinical Trials on FFR via central venous line

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe