Percutaneous Coronary Intervention Registry FRIBOURG (Cardio-FR)

October 14, 2021 updated by: Stéphane Cook, Prof, University of Freiburg
The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital & university Fribourg.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Locations

  • Switzerland
      • Fribourg, Switzerland, 1708
        • Recruiting
        • Cardiology, university Fribourg Medical Center
        • Principal Investigator:
          • Mario Togni, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Serban Puricel, MD
        • Principal Investigator:
          • Diego Arroyo, MD

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

17 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All comers

Description

Inclusion Criteria:

  • All consecutive patients treated by percutaneous coronary intervention at our institution
  • Able to give informed consent and willing to participate

Exclusion Criteria:

  • Unwillingness to participate
  • Enable to provide inform 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite endpoints (POCE)
Time Frame: 2 years
Academic Research Consortium definition
2 years
Major Bleeding
Time Frame: 2 years
Bleeding Academic Research Consortium definition
2 years
Patient-oriented composite endpoints (POCE)
Time Frame: 5 years
Academic Research Consortium definition
5 years
Major Bleeding
Time Frame: 5 years
Bleeding Academic Research Consortium definition
5 years
Patient-oriented composite endpoints (POCE)
Time Frame: 10 years
Academic Research Consortium definition
10 years
Major Bleeding
Time Frame: 10 years
Bleeding Academic Research Consortium definition
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 2 years
Academic Research Consortium definition
2 years
any revascularization
Time Frame: 2 years
Academic Research Consortium definition
2 years
any myocardial infarction
Time Frame: 2 years
Academic Research Consortium definition
2 years

Collaborators and Investigators

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

Sponsor

University of Freiburg

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 (Actual)

May 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003-REP-CER-FR-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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