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

Acute Coronary Syndrome Clinical Trial

— BASE-CFR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080872
• Other study ID #: SA-005
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2010
• Last updated: May 4, 2011
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: The Hospital District of Satakunta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• CFR
CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital	Pori
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary flow reserve (CFR)	CFR at 6-8 months after stent implantation	6-8 months after stent implantation	Yes
Secondary	Coronary flow velocity		at baseline and during adenosine-induced hyperemia	Yes
Secondary	Association of CFR to unendotheliazed stent struts and stent malapposition		6-8 months	Yes