CARDIOBASE Bern PCI Registry

March 6, 2023 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Cardiology, Bern University Hospital
        • Contact:
        • Principal Investigator:
          • Stephan Windecker, Professor Dr. med.
        • Principal Investigator:
          • Lorenz Raeber, PD Dr med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria

  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with death
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with myocardial infarction
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year
Number of patients with stent thrombosis
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year
Number of patients with repeat revascularisation
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year
Number of patients with stroke
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year
Number of patients with bleeding
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year
Number of patients with
Time Frame: At discharge, expected to be on average after 2 days, & at one year
At discharge, expected to be on average after 2 days, & at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137/14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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