<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/NCT01717495</url>
  </required_header>
  <id_info>
    <org_study_id>CAPPesq: 0730/11</org_study_id>
    <nct_id>NCT01717495</nct_id>
  </id_info>
  <brief_title>Thromboembolic Complications After Pacemaker or Implantable Cardioverter-Defibrillator Procedures</brief_title>
  <official_title>Thromboembolic Complications Associated With Pacemaker or Implantable Cardioverter-Defibrillator Procedures: a Prospective Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a large prospective registry of patients submitted to cardiac electronic devices&#xD;
      implantation designed to investigate the incidence, risk factors and prognostic of&#xD;
      thromboembolic complications associated with transvenous lead implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 235.500 cardiac pacemakers and cardioverter-defibrillators are implanted in the US&#xD;
      every year, with an estimated 25,000 new implants in Brazil. Despite its proven clinical&#xD;
      effectiveness and efficacy for a number of clinical conditions such as arrhythmias, the&#xD;
      number of adverse events in the post-implant period remains substantial. Among these&#xD;
      complications, venous obstructions occurs anywhere between 14% and 64% of all patients,&#xD;
      causing devastating consequences such as upper extremity deep venous thrombosis and pulmonary&#xD;
      embolism, ultimately leading to either significant impairment or death. Although&#xD;
      retrospective studies have demonstrated the high incidence of these complications, as a&#xD;
      consequence of a paucity of reliable registries we know next to nothing regarding how these&#xD;
      venous lesions may influence the clinical outcome and mortality of patients, whether&#xD;
      laboratorial markers may contribute to the early diagnosis of venous thrombosis and its&#xD;
      complications, and about properties of diagnostic imaging for the identification of&#xD;
      thromboembolic complications after permanent transvenous leads implantation.&#xD;
&#xD;
      The objective of this study is therefore to propose a significant improvement in an existing&#xD;
      clinical database located within the Heart Institute (INCOR) at the University of Sao Paulo&#xD;
      to enable the provision of answers to a clinical, biomarker, and imaging-related research&#xD;
      questions. Specifically, our aims are to:&#xD;
&#xD;
        -  Aim 1 - Registry infrastructure: In collaboration with professors from Duke University,&#xD;
           we will create a series of improvements to the current database to enable it to serve as&#xD;
           a platform not only for the current studies but also for future longitudinal, randomized&#xD;
           studies. These include the standardization of variables in accordance with international&#xD;
           guidelines, increase in patient retention and the ability to have additional data points&#xD;
           in-between clinical appointments, improvement in the determination of cause of&#xD;
           mortality, data quality monitoring, the creation of an item bank to measure aspects of&#xD;
           quality of life that are specific for this population, as well as the integration of&#xD;
           images and biomarkers to the clinical database.&#xD;
&#xD;
        -  Aim 2 - Diagnostic imaging methods: To identify the incidence of upper extremity deep&#xD;
           venous thrombosis after cardiac devices implantations or reoperation procedures, as&#xD;
           well, the incidence of symptomatic and asymptomatic pulmonary thromboembolism.&#xD;
&#xD;
        -  Aim 3 - Prognostic clinical factors: To study the impact of thromboembolic complications&#xD;
           in the clinical prognostic and mortality of patients;&#xD;
&#xD;
        -  Aim 4 - Prognostic biomarkers: To determine the association between the biomarkers&#xD;
           related with alterations in the hemostasis system and the occurrence of venous&#xD;
           thrombosis (biomarkers: Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2,&#xD;
           thromboxane B, Platelets, Plasminogen)&#xD;
&#xD;
      At the end of this study we will have a registry with one of the largest number of patients&#xD;
      with this condition around the world, fully equipped for future randomized controlled trials.&#xD;
      We will also have a much better understanding regarding clinical, imaging, and biomarkers for&#xD;
      this condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thromboembolic complications</measure>
    <time_frame>Participants will be evaluated at 1, 6, 12 months after the surgical procedure</time_frame>
    <description>Upper extremity deep venous thrombosis Pulmonary embolism All cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Venous lesions</measure>
    <time_frame>Participants will be evaluated at 12 months after the surgical procedure</time_frame>
    <description>Venous stenosis (any degree) detected by subtraction venography</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Bradyarrhythmias</condition>
  <condition>Arrhythmias</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Venous Thrombosis</condition>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Implantation Procedures</arm_group_label>
    <description>Patients submitted to initial pacemaker or ICD implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reoperation Procedures</arm_group_label>
    <description>Patients submitted to pacemaker or implantable cardioverter-defibrillator generator replacements, upgrade procedures and lead extraction</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2, thromboxane B, Platelets,&#xD;
      Plasminogen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Pacemaker/ implantable-cardioverter defibrillator (ICD) / cardiac resynchronization&#xD;
             therapy (CRT) initial implant by transvenous approach or&#xD;
&#xD;
          -  Patients submitted to reoperation procedures, as: pulse generator replacement, implant&#xD;
             of an additional lead, lead extraction, lead repositioning;&#xD;
&#xD;
          -  Subject agreed to participate and signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of venous thromboembolism, coagulopathy or malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Life expectancy of less than one year&#xD;
&#xD;
          -  Contraindication to administration of iodinated contrast (creatinine &gt; 3.0)&#xD;
&#xD;
          -  Unable to attend the follow-up appointments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Costa, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katia R Silva, RN PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roberto Costa, MD PhD</last_name>
    <phone>55-11-2661</phone>
    <phone_ext>5284</phone_ext>
    <email>rcosta@incor.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katia R Silva, RN PhD</last_name>
    <phone>9195978619</phone>
    <email>katia.research@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katia R Silva, RN PhD</last_name>
      <phone>55-11-2661</phone>
      <phone_ext>5284</phone_ext>
      <email>katia.regina@incor.usp.br</email>
    </contact>
    <investigator>
      <last_name>Roberto Costa, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katia R Silva, RN PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martino Martinelli Filho, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mario Terra Filho, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wilson Mathias Jr, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta F Lima, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto A Rached, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claudio L Lucarelli, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francisco C Carnevale, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Airton M Moreira, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wagner T Tamaki, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elizabeth S Crevelari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto M Oliveira Jr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marianna S Lacerda, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>May 4, 2013</last_update_submitted>
  <last_update_submitted_qc>May 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Roberto Costa</investigator_full_name>
    <investigator_title>Associated Professor of Cardiovascular Surgery, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Pacemaker</keyword>
  <keyword>Implantable-cardioverter defibrillator</keyword>
  <keyword>Cardiac Pacing, Artificial/adverse effects</keyword>
  <keyword>Venous thrombosis</keyword>
  <keyword>Pulmonary embolism</keyword>
  <keyword>Phlebography</keyword>
  <keyword>Biological markers</keyword>
  <keyword>Computed tomography angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Bradycardia</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/NCT01717495
org study id: CAPPesq: 0730/11
nct id: NCT01717495
lead sponsor: 
collaborator: 
has dmc: Yes
This is a large prospective registry of patients submitted to cardiac electronic devices
      implantation designed to investigate the incidence, risk factors and prognostic of
      thromboembolic complications associated with transvenous lead implantation.
More than 235.500 cardiac pacemakers and cardioverter-defibrillators are implanted in the US
      every year, with an estimated 25,000 new implants in Brazil. Despite its proven clinical
      effectiveness and efficacy for a number of clinical conditions such as arrhythmias, the
      number of adverse events in the post-implant period remains substantial. Among these
      complications, venous obstructions occurs anywhere between 14% and 64% of all patients,
      causing devastating consequences such as upper extremity deep venous thrombosis and pulmonary
      embolism, ultimately leading to either significant impairment or death. Although
      retrospective studies have demonstrated the high incidence of these complications, as a
      consequence of a paucity of reliable registries we know next to nothing regarding how these
      venous lesions may influence the clinical outcome and mortality of patients, whether
      laboratorial markers may contribute to the early diagnosis of venous thrombosis and its
      complications, and about properties of diagnostic imaging for the identification of
      thromboembolic complications after permanent transvenous leads implantation.

      The objective of this study is therefore to propose a significant improvement in an existing
      clinical database located within the Heart Institute (INCOR) at the University of Sao Paulo
      to enable the provision of answers to a clinical, biomarker, and imaging-related research
      questions. Specifically, our aims are to:

        -  Aim 1 - Registry infrastructure: In collaboration with professors from Duke University,
           we will create a series of improvements to the current database to enable it to serve as
           a platform not only for the current studies but also for future longitudinal, randomized
           studies. These include the standardization of variables in accordance with international
           guidelines, increase in patient retention and the ability to have additional data points
           in-between clinical appointments, improvement in the determination of cause of
           mortality, data quality monitoring, the creation of an item bank to measure aspects of
           quality of life that are specific for this population, as well as the integration of
           images and biomarkers to the clinical database.

        -  Aim 2 - Diagnostic imaging methods: To identify the incidence of upper extremity deep
           venous thrombosis after cardiac devices implantations or reoperation procedures, as
           well, the incidence of symptomatic and asymptomatic pulmonary thromboembolism.

        -  Aim 3 - Prognostic clinical factors: To study the impact of thromboembolic complications
           in the clinical prognostic and mortality of patients;

        -  Aim 4 - Prognostic biomarkers: To determine the association between the biomarkers
           related with alterations in the hemostasis system and the occurrence of venous
           thrombosis (biomarkers: Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2,
           thromboxane B, Platelets, Plasminogen)

      At the end of this study we will have a registry with one of the largest number of patients
      with this condition around the world, fully equipped for future randomized controlled trials.
      We will also have a much better understanding regarding clinical, imaging, and biomarkers for
      this condition.
observational model: Cohort
time perspective: Prospective
measure: Thromboembolic complications
time frame: Participants will be evaluated at 1, 6, 12 months after the surgical procedure
description: Upper extremity deep venous thrombosis Pulmonary embolism All cause mortality
measure: Venous lesions
time frame: Participants will be evaluated at 12 months after the surgical procedure
description: Venous stenosis (any degree) detected by subtraction venography
arm group label: Implantation Procedures
description: Patients submitted to initial pacemaker or ICD implantation
arm group label: Reoperation Procedures
description: Patients submitted to pacemaker or implantable cardioverter-defibrillator generator replacements, upgrade procedures and lead extraction
Blood Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2, thromboxane B, Platelets,
      Plasminogen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Roberto Costa, MD PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Katia R Silva, RN PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Roberto Costa, MD PhD
phone: 55-11-2661
phone ext: 5284
email: rcosta@incor.usp.br
last name: Katia R Silva, RN PhD
phone: 9195978619
email: katia.research@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Roberto Costa
investigator title: Associated Professor of Cardiovascular Surgery, MD PhD
mesh term: Pulmonary Embolism
mesh term: Cardiovascular Diseases
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Bradycardia