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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium-NO coated stent | Patients receiving titanium-nitride-oxide coated stents during the intervention. |
| |
| Everolimus eluting stent | Patients receiving everolimus eluting stents during the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFR | Device | CFR will be assessed using transthoracic echocardiography with adenosine infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary flow reserve (CFR) | CFR at 6-8 months after stent implantation | 6-8 months after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary flow velocity | at baseline and during adenosine-induced hyperemia | |
| Association of CFR to unendotheliazed stent struts and stent malapposition | 6-8 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satakunta Central Hospital | Pori | 28500 | Finland | |||
| Turku University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18312446 | Background | 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. | |
| 23996244 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Turku |
| Finland |