Myocardial IschemiaNCT02241291
CARDIOBASE Bern PCI Registry
An observational study of Myocardial Ischemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective, single-center observational, web-based registry of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital, Switzerland
Who may be able to join
- Patient above 18 years of age
- Undergoing PCI at Bern University Hospital
- Written informed consent
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Cardiology, Bern University Hospital
Bern, 3010
Lorenz Raeber, PD Dr. med., +41 31 632 21 11, lorenz.raeber@insel.ch
Stephan Windecker, Professor Dr. med.
About this study
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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Percutaneous coronary intervention
- Keywords
- Percutaneous Coronary Intervention, Registries
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing PCI at Bern University Hospital Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with death
Measured: At discharge, expected to be on average after 2 days, & at one year
Secondary outcomes (6)
Number of patients with myocardial infarction
Measured: At discharge, expected to be on average after 2 days, & at one year
Number of patients with stent thrombosis
Measured: At discharge, expected to be on average after 2 days, & at one year
Number of patients with repeat revascularisation
Measured: At discharge, expected to be on average after 2 days, & at one year
Number of patients with stroke
Measured: At discharge, expected to be on average after 2 days, & at one year
Number of patients with bleeding
Measured: At discharge, expected to be on average after 2 days, & at one year
Number of patients with
Measured: At discharge, expected to be on average after 2 days, & at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startMar 2009
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Windecker, Professor Dr. med., Principal investigator, Department of Cardiology, Bern University HospitalLorenz Raeber, PD Dr. med., Principal investigator, Department of Cardiology, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241291
- Sponsor's protocol ID
- 137/14
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2014
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19717846Wiviott 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.
PubMed 17982182Gitt 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.
PubMed 20093258Mandelzweig 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.
PubMed 16908490Bar 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.
PubMed 38156592Ueki 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.
PubMed 35171913Ueki 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.
PubMed 35144742Zanchin 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.
PubMed 35033577Otsuka 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.
PubMed 34816730Ueki 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.
PubMed 34396175Spirito 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.
PubMed 34098740Ueki 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.
PubMed 32065586Zanchin 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.
PubMed 31422088Ueki 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.
PubMed 30981574Yamaji 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.
PubMed 30354590
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIOBASE Bern PCI Registry
- ClinicalTrials.gov ID
- NCT02241291
- Acronym / sponsor ID
- 137/14
- Conditions
- Myocardial Ischemia
- Keywords
- Percutaneous Coronary Intervention, Registries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: Percutaneous coronary interventionPatients undergoing PCI at Bern University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective, single-center observational, web-based registry of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital, Switzerland
Key inclusion criteria (3 listed)
- Patient above 18 years of age
- Undergoing PCI at Bern University Hospital
- Written informed consent
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionNon-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 | Procedure or surgery | All patients |
Primary outcome
Number of patients with death
Time frame: At discharge, expected to be on average after 2 days, & at one year
6 secondary outcomes
Number of patients with myocardial infarction
Time frame: 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
Number of patients with repeat revascularisation
Time frame: 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
Number of patients with bleeding
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Results publication: PubMed 19717846Wallentin 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.
- Results publication: PubMed 17982182Wiviott 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.
- Results publication: PubMed 20093258Gitt 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.
- Results publication: PubMed 16908490Mandelzweig 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.
- Derived from this study: PubMed 38156592Bar 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.
- Derived from this study: PubMed 35171913Ueki 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.
- Derived from this study: PubMed 35144742Ueki 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.
- Derived from this study: PubMed 35033577Zanchin 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.
- Derived from this study: PubMed 34816730Otsuka 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.
- Derived from this study: PubMed 34396175Ueki 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.
- Derived from this study: PubMed 34098740Spirito 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.
- Derived from this study: PubMed 32065586Ueki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Windecker, Professor Dr. med. principal investigator
Department of Cardiology, Bern University Hospital
Lorenz Raeber, PD Dr. med. principal investigator
Department of Cardiology, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Raeber, PD Dr. med. (+41 31 632 21 11, lorenz.raeber@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with death (time frame: At discharge, expected to be on average after 2 days, & at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241291, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.