CARDIOBASE Bern PCI Registry

NCT ID: NCT02241291

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Patients undergoing PCI at Bern University Hospital

Percutaneous coronary intervention

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Windecker, Professor Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bern University Hospital

Lorenz Raeber, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bern University Hospital

Locations

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Department of Cardiology, Bern University Hospital

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Lorenz Raeber, PD Dr. med.

Role: CONTACT

+41 31 632 21 11

Facility Contacts

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Lorenz Raeber, PD Dr. med.

Role: primary

+41 31 632 21 11

References

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Reference Type RESULT
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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.

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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.

Reference Type RESULT
PMID: 16908490 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38156592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35171913 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35144742 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35033577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34816730 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34396175 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34098740 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32065586 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31422088 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30981574 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30354590 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30328801 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29748219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29654204 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27296200 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25910501 (View on PubMed)

Other Identifiers

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137/14

Identifier Type: -

Identifier Source: org_study_id

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