NCT01080872

Brief Summary

The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

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
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

1.4 years

First QC Date

March 3, 2010

Last Update Submit

May 4, 2011

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndromecoronary flow reserveOCThealingdrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Coronary flow reserve (CFR)

    CFR at 6-8 months after stent implantation

    6-8 months after stent implantation

Secondary Outcomes (2)

  • Coronary flow velocity

    at baseline and during adenosine-induced hyperemia

  • Association of CFR to unendotheliazed stent struts and stent malapposition

    6-8 months

Study Arms (2)

Titanium-NO coated stent

Patients receiving titanium-nitride-oxide coated stents during the intervention.

Device: CFR

Everolimus eluting stent

Patients receiving everolimus eluting stents during the intervention.

Device: CFR

Interventions

CFRDEVICE

CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Also known as: Xience-V stent, Abbott vascular, USA
Everolimus eluting stentTitanium-NO coated stent

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.

You may qualify if:

  • The patient is enrolled to the BASE-ACS trial. Treated culprit lesion is in the proximal or middle LAD
  • Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site

You may not qualify if:

  • Diabetes mellitus
  • Treated stent position other than LAD proximal or middle.
  • EF\<30%
  • Bifurcation lesions
  • Renal impairment (creatinine \>120 mmol/L)
  • No suitable anatomy for OCT scan or CFR measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Satakunta Central Hospital

Pori, 28500, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (2)

  • Kiviniemi T. Assessment of coronary blood flow and the reactivity of the microcirculation non-invasively with transthoracic echocardiography. Clin Physiol Funct Imaging. 2008 May;28(3):145-55. doi: 10.1111/j.1475-097X.2008.00794.x. Epub 2008 Feb 26.

    PMID: 18312446BACKGROUND

  • Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31.

    PMID: 23996244DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Tuomas O Kiviniemi, MD PhD

    Satakunta Central Hospital

    STUDY CHAIR

  • Antti Saraste, MD PhD

    Turku University Hospital

    STUDY CHAIR

  • Pasi P Karjalainen, MD PhD

    Satakunta Central Hospital

    PRINCIPAL INVESTIGATOR

  • Antti Ylitalo, MD PhD

    Satakunta Central Hospital

    STUDY DIRECTOR

  • Jussi Mikkelsson, MD PhD

    Satakunta Central Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

FI(2)