CARDIOBASE Bern PCI Registry
- Conditions
- Myocardial Ischemia
- Interventions
- Procedure: Percutaneous coronary intervention
- Registration Number
- NCT02241291
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- Patient above 18 years of age
- Undergoing PCI at Bern University Hospital
- Written informed consent
Exclusion Criteria
- No informed consent
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All patients Percutaneous coronary intervention Patients undergoing PCI at Bern University Hospital
- Primary Outcome Measures
Name Time Method Number of patients with death At discharge, expected to be on average after 2 days, & at one year
- Secondary Outcome Measures
Name Time Method 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 stroke 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 Number of patients with repeat revascularisation 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
Trial Locations
- Locations (1)
Department of Cardiology, Bern University Hospital
🇨đź‡Bern, Switzerland