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

NCT ID: NCT01070420

Last Updated: 2011-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Myocardial Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FFR via central venous line

Group Type ACTIVE_COMPARATOR

FFR via central venous line

Intervention Type OTHER

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.

FFR via peripheral vein

Group Type EXPERIMENTAL

FFR via peripheral venous line

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cardiovascular Center, Seoul National University Hospital,

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bon- Kwon Koo, MD, PhD

Role: STUDY_CHAIR

Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Her SH, Hur SH, Park JS, Kim MK, Choi YS, Kim HS, Cho JH, Lee SG, Park YW, Jeong MH, Lee BK, Lee NH, Lim DS, Yoon J, Seung KB, Shin WY, Rha SW, Kim KS, Tahk SJ, Park BE, Ahn T, Yang JY, Jeong YS, Rhew JH, Park SJ; IRIS-DES Investigators. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study. Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.

Reference Type DERIVED
PMID: 22693347 (View on PubMed)

Seo MK, Koo BK, Kim JH, Shin DH, Yang HM, Park KW, Lee HY, Kang HJ, Kim HS, Oh BH, Park YB. Comparison of hyperemic efficacy between central and peripheral venous adenosine infusion for fractional flow reserve measurement. Circ Cardiovasc Interv. 2012 Jun;5(3):401-5. doi: 10.1161/CIRCINTERVENTIONS.111.965392. Epub 2012 May 29.

Reference Type DERIVED
PMID: 22647519 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D-0910-002-062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.