<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02241291</url>
  </required_header>
  <id_info>
    <org_study_id>137/14</org_study_id>
    <nct_id>NCT02241291</nct_id>
  </id_info>
  <brief_title>CARDIOBASE Bern PCI Registry</brief_title>
  <official_title>CARDIOBASE Bern PCI Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural&#xD;
      data as well as to assess the clinical outcomes of all patients undergoing percutaneous&#xD;
      coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or&#xD;
      without stent implantation will be prospectively registered. Device use is according to the&#xD;
      decision of the treating physician and independent of this registry. At hospital discharge&#xD;
      and one year, the following outcomes will be assessed: death, cardiac death, myocardial&#xD;
      infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding,&#xD;
      renal failure and vascular complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Percutaneous Coronary Intervention (PCI) is the most frequently medical intervention&#xD;
      performed worldwide. Coronary heart disease (CAD) remains the leading cause of death,&#xD;
      although advances in the management of acute myocardial infarction (MI) have reduced&#xD;
      in-hospital mortality from 16% in the mid-1980s to around 4 to 6%. Several breakthroughs have&#xD;
      accounted for improvement of cardiovascular outcomes, including the use and further&#xD;
      improvement of coronary stents and antiplatelet therapy. Regarding stents, bare metal stents&#xD;
      were first introduced but associated with a high risk of restenosis, something which was&#xD;
      successfully addressed by the introduction of drug-eluting stents.&#xD;
&#xD;
      All benefits and shortcomings of newly introduced devices and drug therapies are evaluated in&#xD;
      large randomized controlled trials (RCT). Registries provide useful insights into novel&#xD;
      associations that cannot be addressed by RCT.&#xD;
&#xD;
      The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural&#xD;
      data as well as to assess the clinical outcomes of all patients undergoing percutaneous&#xD;
      coronary intervention at Bern University Hospital. All patients undergoing PCI with or&#xD;
      without stent implantation will be prospectively registered. Device use is according to the&#xD;
      decision of the treating physician and independent of this registry.&#xD;
&#xD;
      Objective&#xD;
&#xD;
      Prospectively collect baseline clinical, procedural and clinical outcomes at discharge and&#xD;
      one year in order to assess the safety and efficacy of PCI at Bern University Hospital.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      ECGs of all patients will be analyzed and a correlation with clinical outcome data performed.&#xD;
      Outcomes will be compared in different clinical subgroups. The impact of stent devices&#xD;
      implanted and the anti-platelet therapy regimen on cardiovascular outcomes will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with death</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with myocardial infarction</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with stent thrombosis</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with repeat revascularisation</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with stroke</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with bleeding</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with</measure>
    <time_frame>At discharge, expected to be on average after 2 days, &amp; at one year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <description>Patients undergoing PCI at Bern University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <description>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</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective, single-center observational, web-based registry of all patients undergoing&#xD;
        percutaneous coronary intervention (PCI) at Bern University Hospital, Switzerland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient above 18 years of age&#xD;
&#xD;
          -  Undergoing PCI at Bern University Hospital&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  No informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Windecker, Professor Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Bern University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lorenz Raeber, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Bern University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorenz Raeber, PD Dr. med.</last_name>
    <phone>+41 31 632 21 11</phone>
    <email>lorenz.raeber@insel.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Cardiology, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorenz Raeber, PD Dr. med.</last_name>
      <phone>+41 31 632 21 11</phone>
      <email>lorenz.raeber@insel.ch</email>
    </contact>
    <investigator>
      <last_name>Stephan Windecker, Professor Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lorenz Raeber, PD Dr med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <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 patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.</citation>
    <PMID>19717846</PMID>
  </results_reference>
  <results_reference>
    <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 coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.</citation>
    <PMID>17982182</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>20093258</PMID>
  </results_reference>
  <results_reference>
    <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, 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.</citation>
    <PMID>16908490</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Registries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02241291
org study id: 137/14
nct id: NCT02241291
lead sponsor: 
has dmc: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Number of patients with death
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with myocardial infarction
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with stent thrombosis
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with repeat revascularisation
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with stroke
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with bleeding
time frame: At discharge, expected to be on average after 2 days, & at one year
measure: Number of patients with
time frame: At discharge, expected to be on average after 2 days, & at one year
arm group label: All patients
description: Patients undergoing PCI at Bern University Hospital
intervention type: Procedure
intervention name: Percutaneous coronary intervention
description: 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
arm group label: All patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan Windecker, Professor Dr. med.
role: Principal Investigator
affiliation: Department of Cardiology, Bern University Hospital
last name: Lorenz Raeber, PD Dr. med.
role: Principal Investigator
affiliation: Department of Cardiology, Bern University Hospital
last name: Lorenz Raeber, PD Dr. med.
phone: +41 31 632 21 11
email: lorenz.raeber@insel.ch
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Switzerland
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 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: 19717846
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 coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
PMID: 17982182
citation: 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: 20093258
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, 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: 16908490
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Ischemia