CARDIOBASE Bern PCI Registry

Myocardial Ischemia Clinical Trial

Official title:

CARDIOBASE Bern PCI Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02241291
• Other study ID #: 137/14
• Status: Recruiting
• Start date: March 2009
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Lorenz Raeber, PD Dr. med.
• Phone: +41 31 632 21 11
• Email: lorenz.raeber[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient above 18 years of age

• Undergoing PCI at Bern University Hospital

• Written informed consent

Exclusion Criteria

• No informed consent

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Cardiology, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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, tr — View Citation

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 patient — View Citation

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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with death		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with myocardial infarction		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with stent thrombosis		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with repeat revascularisation		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with stroke		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with bleeding		At discharge, expected to be on average after 2 days, & at one year
Secondary	Number of patients with		At discharge, expected to be on average after 2 days, & at one year