Clinical trial NCT02241291: CARDIOBASE Bern PCI Registry
Official title: CARDIOBASE Bern PCI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Ischemia
Keywords: Percutaneous Coronary Intervention
Registries
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective, single-center observational, web-based registry of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital, Switzerland

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.

Eligibility criteria: Inclusion Criteria:

* Patient above 18 years of age
* Undergoing PCI at Bern University Hospital
* Written informed consent

Exclusion Criteria

* No informed consent

Primary outcomes:
measure: Number of patients with death
timeFrame: At discharge, expected to be on average after 2 days, & at one year
Secondary outcomes:
measure: Number of patients with myocardial infarction
timeFrame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with stent thrombosis
timeFrame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with repeat revascularisation
timeFrame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with stroke
timeFrame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with bleeding
timeFrame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with
timeFrame: At discharge, expected to be on average after 2 days, & at one year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Cardiology, Bern University Hospital
Study officials:
affiliation: Department of Cardiology, Bern University Hospital
name: Stephan Windecker, Professor Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Bern University Hospital
name: Lorenz Raeber, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
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