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CARDIOBASE Bern PCI Registry

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ClinicalTrials.gov Identifier: NCT02241291
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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
Myocardial Ischemia Procedure: Percutaneous coronary intervention

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
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: CARDIOBASE Bern PCI Registry
Study Start Date : March 2009
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Groups and Cohorts
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Group/Cohort 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with death [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]

Secondary Outcome Measures :
  1. Number of patients with myocardial infarction [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]
  2. Number of patients with stent thrombosis [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]
  3. Number of patients with repeat revascularisation [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]
  4. Number of patients with stroke [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]
  5. Number of patients with bleeding [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]
  6. Number of patients with [ Time Frame: At discharge, expected to be on average after 2 days, & at one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • No informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241291


Contacts
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Contact: Lorenz Raeber, PD Dr. med. +41 31 632 21 11 lorenz.raeber@insel.ch

Locations
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Switzerland
Department of Cardiology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Lorenz Raeber, PD Dr. med.    +41 31 632 21 11    lorenz.raeber@insel.ch   
Principal Investigator: Stephan Windecker, Professor Dr. med.         
Principal Investigator: Lorenz Raeber, PD Dr med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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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
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02241291    
Other Study ID Numbers: 137/14
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Keywords provided by University Hospital Inselspital, Berne:
Percutaneous Coronary Intervention
Registries
Additional relevant MeSH terms:
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Myocardial Ischemia
Ischemia
Pathologic Processes
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases