Acute Coronary SyndromeBASE-CFRNCT01080872
Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by The Hospital District of Satakunta at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- CFR
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- Dec 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Satakunta Central Hospital
Pori, 28500
Turku University Hospital
Turku
About this study
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.
Read the 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
- Conditions
- Acute Coronary Syndrome
- Being tested
- CFR
- Keywords
- acute coronary syndrome, coronary flow reserve, OCT, healing, drug eluting stent
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFRDevice
Also called Xience-V stent, Abbott vascular, USA
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
| Study group | Role | What they receive |
|---|---|---|
| Titanium-NO coated stent | Patients receiving titanium-nitride-oxide coated stents during the intervention. Receives: Device: CFR | |
| Everolimus eluting stent | Patients receiving everolimus eluting stents during the intervention. Receives: Device: CFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow reserve (CFR)
CFR at 6-8 months after stent implantation
Measured: 6-8 months after stent implantation
Secondary outcomes (2)
Coronary flow velocity
Measured: at baseline and during adenosine-induced hyperemia
Association of CFR to unendotheliazed stent struts and stent malapposition
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Investigators
- Tuomas O Kiviniemi, MD PhD, Study chair, Satakunta Central HospitalAntti Saraste, MD PhD, Study chair, Turku University HospitalPasi P Karjalainen, MD PhD, Principal investigator, Satakunta Central HospitalAntti Ylitalo, MD PhD, Study director, Satakunta Central HospitalJussi Mikkelsson, MD PhD, Study chair, Satakunta Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080872
- Sponsor's protocol ID
- SA-005
- Acronym
- BASE-CFR
- Status last verified
- May 2011
- First submitted
- 3 Mar 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18312446Karjalainen 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.
PubMed 23996244
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01080872
- Acronym / sponsor ID
- BASE-CFR / SA-005
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, coronary flow reserve, OCT, healing, drug eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium-NO coated stent | – | Device: CFRPatients receiving titanium-nitride-oxide coated stents during the intervention. |
| Everolimus eluting stent | – | Device: CFRPatients receiving everolimus eluting stents during the intervention. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Diabetes mellitus
- Treated stent position other than LAD proximal or middle.
- EF<30%
- Bifurcation lesions
- Renal impairment (creatinine >120 mmol/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFRAlso: Xience-V stent, Abbott vascular, USACFR will be assessed using transthoracic echocardiography with adenosine infusion. | Device | Everolimus eluting stent, Titanium-NO coated stent |
Primary outcome
Coronary flow reserve (CFR)
Time frame: 6-8 months after stent implantation
CFR at 6-8 months after stent implantation
2 secondary outcomes
Coronary flow velocity
Time frame: at baseline and during adenosine-induced hyperemia
Association of CFR to unendotheliazed stent struts and stent malapposition
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Background: PubMed 18312446Kiviniemi 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.
- Derived from this study: PubMed 23996244Karjalainen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuomas O Kiviniemi, MD PhD study chair
Satakunta Central Hospital
Antti Saraste, MD PhD study chair
Turku University Hospital
Pasi P Karjalainen, MD PhD principal investigator
Satakunta Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by The Hospital District of Satakunta at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary flow reserve (CFR) (time frame: 6-8 months after stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080872, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.