CARDIOBASE Bern PCI Registry
Study Details
Study Description
Brief Summary
The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or without stent implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry. At hospital discharge and one year, the following outcomes will be assessed: death, cardiac death, myocardial infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding, renal failure and vascular complications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Background
Percutaneous Coronary Intervention (PCI) is the most frequently medical intervention performed worldwide. Coronary heart disease (CAD) remains the leading cause of death, although advances in the management of acute myocardial infarction (MI) have reduced in-hospital mortality from 16% in the mid-1980s to around 4 to 6%. Several breakthroughs have accounted for improvement of cardiovascular outcomes, including the use and further improvement of coronary stents and antiplatelet therapy. Regarding stents, bare metal stents were first introduced but associated with a high risk of restenosis, something which was successfully addressed by the introduction of drug-eluting stents.
All benefits and shortcomings of newly introduced devices and drug therapies are evaluated in large randomized controlled trials (RCT). Registries provide useful insights into novel associations that cannot be addressed by RCT.
The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention at Bern University Hospital. All patients undergoing PCI with or without stent implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Objective
Prospectively collect baseline clinical, procedural and clinical outcomes at discharge and one year in order to assess the safety and efficacy of PCI at Bern University Hospital.
Methods
ECGs of all patients will be analyzed and a correlation with clinical outcome data performed. Outcomes will be compared in different clinical subgroups. The impact of stent devices implanted and the anti-platelet therapy regimen on cardiovascular outcomes will be assessed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All patients Patients undergoing PCI at Bern University Hospital |
Procedure: Percutaneous coronary intervention
Non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. A deflated balloon or other device on a catheter is fed from an artery (such as the inguinal femoral artery or radial artery) up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery
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Outcome Measures
Primary Outcome Measures
- Number of patients with death [At discharge, expected to be on average after 2 days, & at one year]
Secondary Outcome Measures
- Number of patients with myocardial infarction [At discharge, expected to be on average after 2 days, & at one year]
- Number of patients with stent thrombosis [At discharge, expected to be on average after 2 days, & at one year]
- Number of patients with repeat revascularisation [At discharge, expected to be on average after 2 days, & at one year]
- Number of patients with stroke [At discharge, expected to be on average after 2 days, & at one year]
- Number of patients with bleeding [At discharge, expected to be on average after 2 days, & at one year]
- Number of patients with [At discharge, expected to be on average after 2 days, & at one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient above 18 years of age
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Undergoing PCI at Bern University Hospital
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Written informed consent
Exclusion Criteria
- No informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, Bern University Hospital | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Stephan Windecker, Professor Dr. med., Department of Cardiology, Bern University Hospital
- Principal Investigator: Lorenz Raeber, PD Dr. med., Department of Cardiology, Bern University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 137/14