Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome (BASE-CFR)

May 4, 2011 updated by: The Hospital District of Satakunta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: 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.

Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome. CFR assessment will be performed at 6-8 months after stent implantation at the same time with OCT assessment. In-stent restenosis will be ruled out using OCT.

Primary endpoint: CFR at 6-8 months after stent implantation.

Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia 6-8 months after stent implantation..

Association of CFR to unendotheliazed stent struts and stent malapposition.

Enrollment: 40 patients (20 receiving BAS and 20 receiving EES).

Clinical site: Satakunta Central Hospital, Finland Turku University Hospital, Finland

Study Type

Observational

Enrollment (Anticipated)

40

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

  • Finland
      • Pori, Finland, 28500
        • Satakunta Central Hospital
      • Turku, Finland
        • Turku 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

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Titanium-NO coated stent
Patients receiving titanium-nitride-oxide coated stents during the intervention.
Device: CFR
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Names:
  • Xience-V stent, Abbott vascular, USA
Everolimus eluting stent
Patients receiving everolimus eluting stents during the intervention.
Device: CFR
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Names:
  • Xience-V stent, Abbott vascular, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow reserve (CFR)
Time Frame: 6-8 months after stent implantation
CFR at 6-8 months after stent implantation
6-8 months after stent implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Coronary flow velocity
Time Frame: at baseline and during adenosine-induced hyperemia
at baseline and during adenosine-induced hyperemia
Association of CFR to unendotheliazed stent struts and stent malapposition
Time Frame: 6-8 months
6-8 months

Collaborators and Investigators

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

Sponsor

The Hospital District of Satakunta

Investigators

  • Study Chair: Tuomas O Kiviniemi, MD PhD, Satakunta Central Hospital
  • Study Chair: Antti Saraste, MD PhD, Turku University Hospital
  • Principal Investigator: Pasi P Karjalainen, MD PhD, Satakunta Central Hospital
  • Study Director: Antti Ylitalo, MD PhD, Satakunta Central Hospital
  • Study Chair: Jussi Mikkelsson, MD PhD, Satakunta Central 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)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2011

Last Update Submitted That Met QC Criteria

May 4, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-005

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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