NCT02241291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

16.3 years

First QC Date

September 11, 2014

Last Update Submit

March 6, 2023

Conditions

Myocardial Ischemia

Keywords

Percutaneous Coronary InterventionRegistries

Outcome Measures

Primary Outcomes (1)

  • Number of patients with death

    At discharge, expected to be on average after 2 days, & at one year

Secondary Outcomes (6)

  • 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 repeat revascularisation

    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 bleeding

    At discharge, expected to be on average after 2 days, & at one year

  • +1 more secondary outcomes

Study Arms (1)

All patients

Patients undergoing PCI at Bern University Hospital

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE

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

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective, single-center observational, web-based registry of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital, Switzerland

You may qualify if:

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

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (20)

  • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

    PMID: 19717846RESULT

  • Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.

    PMID: 17982182RESULT

  • Gitt AK, Bueno H, Danchin N, Fox K, Hochadel M, Kearney P, Maggioni AP, Opolski G, Seabra-Gomes R, Weidinger F. The role of cardiac registries in evidence-based medicine. Eur Heart J. 2010 Mar;31(5):525-9. doi: 10.1093/eurheartj/ehp596. Epub 2010 Jan 20. No abstract available.

    PMID: 20093258RESULT

  • Mandelzweig L, Battler A, Boyko V, Bueno H, Danchin N, Filippatos G, Gitt A, Hasdai D, Hasin Y, Marrugat J, Van de Werf F, Wallentin L, Behar S; Euro Heart Survey Investigators. The second Euro Heart Survey on acute coronary syndromes: Characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J. 2006 Oct;27(19):2285-93. doi: 10.1093/eurheartj/ehl196. Epub 2006 Aug 14.

    PMID: 16908490RESULT

  • Bar S, Kavaliauskaite R, Otsuka T, Ueki Y, Haner J, Lanz J, Furholz M, Praz F, Hunziker L, Siontis GC, Pilgrim T, Stortecky S, Losdat S, Windecker S, Raber L. Quantitative Flow Ratio to Predict Non-Target-Vessel Events Before Planned Staged Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2024 Jan 2;13(1):e031847. doi: 10.1161/JAHA.123.031847. Epub 2023 Dec 29.

    PMID: 38156592DERIVED

  • Ueki Y, Zanchin T, Losdat S, Karagiannis A, Otsuka T, Siontis GCM, Haner J, Stortecky S, Pilgrim T, Valgimigli M, Windecker S, Raber L. Self-reported non-adherence to P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: Application of the medication non-adherence academic research consortium classification. PLoS One. 2022 Feb 16;17(2):e0263180. doi: 10.1371/journal.pone.0263180. eCollection 2022.

    PMID: 35171913DERIVED

  • Ueki Y, Otsuka T, Bar S, Koskinas KC, Heg D, Haner J, Siontis GCM, Praz F, Hunziker L, Lanz J, Stortecky S, Pilgrim T, Losdat S, Windecker S, Raber L. Frequency and Outcomes of Periprocedural MI in Patients With Chronic Coronary Syndromes Undergoing PCI. J Am Coll Cardiol. 2022 Feb 15;79(6):513-526. doi: 10.1016/j.jacc.2021.11.047.

    PMID: 35144742DERIVED

  • Zanchin C, Ledwoch S, Bar S, Ueki Y, Otsuka T, Haner JD, Zanchin T, Praz F, Hunziker L, Stortecky S, Pilgrim T, Losdat S, Windecker S, Raber L, Siontis GCM. Acute coronary syndromes in young patients: Phenotypes, causes and clinical outcomes following percutaneous coronary interventions. Int J Cardiol. 2022 Mar 1;350:1-8. doi: 10.1016/j.ijcard.2022.01.018. Epub 2022 Jan 13.

    PMID: 35033577DERIVED

  • Otsuka T, Bar S, Losdat S, Kavaliauskaite R, Ueki Y, Zanchin C, Lanz J, Praz F, Haner J, Siontis GCM, Zanchin T, Stortecky S, Pilgrim T, Windecker S, Raber L. Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2021 Dec 7;10(23):e023129. doi: 10.1161/JAHA.121.023129. Epub 2021 Nov 24.

    PMID: 34816730DERIVED

  • Ueki Y, Vogeli B, Karagiannis A, Zanchin T, Zanchin C, Rhyner D, Otsuka T, Praz F, Siontis GCM, Moro C, Stortecky S, Billinger M, Valgimigli M, Pilgrim T, Windecker S, Suter T, Raber L. Ischemia and Bleeding in Cancer Patients Undergoing Percutaneous Coronary Intervention. JACC CardioOncol. 2019 Dec 17;1(2):145-155. doi: 10.1016/j.jaccao.2019.11.001. eCollection 2019 Dec.

    PMID: 34396175DERIVED

  • Spirito A, Gragnano F, Corpataux N, Vaisnora L, Galea R, Svab S, Gargiulo G, Siontis GCM, Praz F, Lanz J, Billinger M, Hunziker L, Stortecky S, Pilgrim T, Capodanno D, Urban P, Pocock S, Mehran R, Heg D, Windecker S, Raber L, Valgimigli M. Sex-Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria. J Am Heart Assoc. 2021 Jun 15;10(12):e021965. doi: 10.1161/JAHA.121.021965. Epub 2021 Jun 8.

    PMID: 34098740DERIVED

  • Ueki Y, Bar S, Losdat S, Otsuka T, Zanchin C, Zanchin T, Gragnano F, Gargiulo G, Siontis GCM, Praz F, Lanz J, Hunziker L, Stortecky S, Pilgrim T, Heg D, Valgimigli M, Windecker S, Raber L. Validation of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in patients undergoing percutaneous coronary intervention and comparison with contemporary bleeding risk scores. EuroIntervention. 2020 Aug 28;16(5):371-379. doi: 10.4244/EIJ-D-20-00052.

    PMID: 32065586DERIVED

  • Zanchin C, Ueki Y, Zanchin T, Haner J, Otsuka T, Stortecky S, Koskinas KC, Siontis GCM, Praz F, Moschovitis A, Hunziker L, Valgimigli M, Pilgrim T, Heg D, Windecker S, Raber L. Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1665-1675. doi: 10.1016/j.jcin.2019.04.046. Epub 2019 Aug 14.

    PMID: 31422088DERIVED

  • Ueki Y, Karagiannis A, Zanchin C, Zanchin T, Stortecky S, Koskinas KC, Siontis GCM, Praz F, Otsuka T, Hunziker L, Heg D, Moschovitis A, Seiler C, Billinger M, Pilgrim T, Valgimigli M, Windecker S, Raber L. Validation of High-Risk Features for Stent-Related Ischemic Events as Endorsed by the 2017 DAPT Guidelines. JACC Cardiovasc Interv. 2019 May 13;12(9):820-830. doi: 10.1016/j.jcin.2018.12.005. Epub 2019 Apr 10.

    PMID: 30981574DERIVED

  • Yamaji K, Zanchin T, Zanchin C, Stortecky S, Koskinas KC, Hunziker L, Praz F, Blochlinger S, Moro C, Moschovitis A, Seiler C, Valgimigli M, Billinger M, Pilgrim T, Heg D, Windecker S, Raber L. Unselected Use of Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Coronary Revascularization. Circ Cardiovasc Interv. 2018 Sep;11(9):e006741. doi: 10.1161/CIRCINTERVENTIONS.118.006741.

    PMID: 30354590DERIVED

  • Li J, Wyrsch D, Heg D, Stoller M, Zanchin T, Perrin T, Windecker S, Raber L, Roten L. Electrocardiographic predictors of mortality in patients after percutaneous coronary interventions - a nested case-control study. Acta Cardiol. 2019 Aug;74(4):341-349. doi: 10.1080/00015385.2018.1494117. Epub 2018 Oct 17.

    PMID: 30328801DERIVED

  • Zanchin T, Temperli F, Karagiannis A, Zanchin C, Rasanen M, Koskinas KC, Stortecky S, Hunziker L, Praz F, Blochlinger S, Moro C, Moschovitis A, Seiler C, Billinger M, Heg D, Pilgrim T, Valgimigli M, Windecker S, Raber L. Frequency, Reasons, and Impact of Premature Ticagrelor Discontinuation in Patients Undergoing Coronary Revascularization in Routine Clinical Practice: Results From the Bern Percutaneous Coronary Intervention Registry. Circ Cardiovasc Interv. 2018 May;11(5):e006132. doi: 10.1161/CIRCINTERVENTIONS.117.006132.

    PMID: 29748219DERIVED

  • Koskinas KC, Zanchin T, Klingenberg R, Gencer B, Temperli F, Baumbach A, Roffi M, Moschovitis A, Muller O, Tuller D, Stortecky S, Mach F, Luscher TF, Matter CM, Pilgrim T, Heg D, Windecker S, Raber L. Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST-Elevation Myocardial Infarction. J Am Heart Assoc. 2018 Apr 13;7(8):e008085. doi: 10.1161/JAHA.117.008085.

    PMID: 29654204DERIVED

  • Zanchin T, Raber L, Koskinas KC, Piccolo R, Juni P, Pilgrim T, Stortecky S, Khattab AA, Wenaweser P, Bloechlinger S, Moschovitis A, Frenk A, Moro C, Meier B, Fiedler GM, Heg D, Windecker S. Preprocedural High-Sensitivity Cardiac Troponin T and Clinical Outcomes in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2016 Jun;9(6):e003202. doi: 10.1161/CIRCINTERVENTIONS.115.003202.

    PMID: 27296200DERIVED

  • Koskinas KC, Raber L, Zanchin T, Wenaweser P, Stortecky S, Moschovitis A, Khattab AA, Pilgrim T, Blochlinger S, Moro C, Juni P, Meier B, Heg D, Windecker S. Clinical impact of gastrointestinal bleeding in patients undergoing percutaneous coronary interventions. Circ Cardiovasc Interv. 2015 May;8(5):e002053. doi: 10.1161/CIRCINTERVENTIONS.114.002053.

    PMID: 25910501DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Stephan Windecker, Professor Dr. med.

    Department of Cardiology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

  • Lorenz Raeber, PD Dr. med.

    Department of Cardiology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Raeber, PD Dr. med.

CONTACT

+41 31 632 21 11lorenz.raeber@insel.ch

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 16, 2014

Study Start

March 1, 2009

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

CH(1)