Clinical trial NCT01080872: Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
Official title: Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
coronary flow reserve
OCT
healing
drug eluting stent
Lead sponsor: The Hospital District of Satakunta
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Coronary flow reserve (CFR)
timeFrame: 6-8 months after stent implantation
Secondary outcomes:
measure: Coronary flow velocity
timeFrame: at baseline and during adenosine-induced hyperemia
measure: Association of CFR to unendotheliazed stent struts and stent malapposition
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Satakunta Central Hospital
name: Tuomas O Kiviniemi, MD PhD
role: STUDY_CHAIR
affiliation: Turku University Hospital
name: Antti Saraste, MD PhD
role: STUDY_CHAIR
affiliation: Satakunta Central Hospital
name: Pasi P Karjalainen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Satakunta Central Hospital
name: Antti Ylitalo, MD PhD
role: STUDY_DIRECTOR
affiliation: Satakunta Central Hospital
name: Jussi Mikkelsson, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.