- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080872
Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome (BASE-CFR)
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pori, Finland, 28500
- Satakunta Central Hospital
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Turku, Finland
- Turku University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Titanium-NO coated stent
Patients receiving titanium-nitride-oxide coated stents during the intervention.
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CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Names:
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Everolimus eluting stent
Patients receiving everolimus eluting stents during the intervention.
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CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Names:
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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
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CFR at 6-8 months after stent implantation
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6-8 months after stent implantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Coronary flow velocity
Time Frame: at baseline and during adenosine-induced hyperemia
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at baseline and during adenosine-induced hyperemia
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Association of CFR to unendotheliazed stent struts and stent malapposition
Time Frame: 6-8 months
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6-8 months
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Collaborators and Investigators
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
General Publications
- 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.
- 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. Erratum In: Int J Cardiovasc Imaging. 2013 Dec;29(8):1915. Kiviniemi, Tuomas O [added]; Lehtinen, Tuomas [added]; Nammas, Wail [added]; Ylitalo, Antti [added]; Saraste, Antti [added]; Mikkelsson, Jussi [added]; Pietila, Mikko [added]; Biancari, Fausto [added]; Airaksinen, Juhani K E [added].
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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