NCT01070420

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

January 10, 2010

Last Update Submit

July 15, 2011

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

AdenosineFractional flow reserve, HyperemiaFractional Flow Reserve, Myocardial

Outcome Measures

Primary Outcomes (1)

  • compare fractional flow reserve at maximal hyperemia

    interval of 10 minutes

Secondary Outcomes (1)

  • compare the time to maximal hyperemia and changes in heart rate

    interval of 10 minutes

Study Arms (2)

FFR via central venous line

ACTIVE COMPARATOR
Other: FFR via central venous line

FFR via peripheral vein

EXPERIMENTAL
Other: FFR via peripheral venous line

Interventions

FFR via central venous lineOTHER

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 central venous line
FFR via peripheral venous lineOTHER

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.

FFR via peripheral vein

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • non -infarct related, patients with moderate coronary artery stenosis
  • normal ejection fraction on echocardiogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Center, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 22693347DERIVED

  • 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.

    PMID: 22647519DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaHyperemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bon- Kwon Koo, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2010

First Posted

February 18, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

KR(1)