<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/NCT03281395</url>
  </required_header>
  <id_info>
    <org_study_id>17/16/205-2</org_study_id>
    <nct_id>NCT03281395</nct_id>
  </id_info>
  <brief_title>Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain</brief_title>
  <official_title>Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time&#xD;
      during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood&#xD;
      pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods&#xD;
      of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be&#xD;
      undetected. The investigator will study the safety of RVP, particularly for the heart and the&#xD;
      brain, retrograde by studying troponin levels and magnetic resonance imaging or computed&#xD;
      tomography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time&#xD;
      during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood&#xD;
      pressure which presents as an on-off phenomenon. The technique facilitates the dissection and&#xD;
      manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be&#xD;
      lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood&#xD;
      pressure and clinical outcome were used as study parameters. However it is not clear whether&#xD;
      repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral&#xD;
      infarcts may be undetected if only clinical outcome is taken as a study parameter. In this&#xD;
      retrograde study, the investigators will study the safety of RVP, particularly for the heart&#xD;
      and the brain, using magnetic resonance imaging or computed tomography and troponin levels.&#xD;
      The purpose of this study is to evaluate the effect of repetitive periods of RVP on the&#xD;
      oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both&#xD;
      markers for ischemia damage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2011</start_date>
  <completion_date type="Actual">July 15, 2013</completion_date>
  <primary_completion_date type="Actual">January 15, 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)</measure>
    <time_frame>A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery</time_frame>
    <description>For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance imaging or computed tomography</measure>
    <time_frame>Preoperative and within 1 week post surgery</time_frame>
    <description>Magnetic resonance imaging or computed tomography of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on)and fossa posterior will be evaluated.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Cardiac Pacing, Artificial</condition>
  <condition>Aneurysm, Brain</condition>
  <condition>Arteriovenous Malformations, Cerebral</condition>
  <arm_group>
    <arm_group_label>Cerebral aneurysm surgery with RVP</arm_group_label>
    <description>During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Craniotomy without RVP</arm_group_label>
    <description>No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rapid ventricular pacing (RVP)</intervention_name>
    <description>Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.</description>
    <arm_group_label>Cerebral aneurysm surgery with RVP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No rapid ventricular pacing</intervention_name>
    <arm_group_label>Craniotomy without RVP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients older than 18 years, schedulled for elective brain surgery and not responding to&#xD;
        any of the exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  elective cerebral aneurysm clipping surgery&#xD;
&#xD;
          -  arteriovenous malformation surgery&#xD;
&#xD;
          -  craniotomy&#xD;
&#xD;
          -  American Society of Anesthesiologists 1,2 and 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac abnormalities&#xD;
&#xD;
          -  coronary heart disease&#xD;
&#xD;
          -  valvular heart disease&#xD;
&#xD;
          -  pregnancy&#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>Vera Saldien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tomas Menovsky, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Joke De Wachter</investigator_full_name>
    <investigator_title>data manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Intracranial Arteriovenous Malformations</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Arteriovenous Malformations</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/NCT03281395
org study id: 17/16/205-2
nct id: NCT03281395
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time
      during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood
      pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods
      of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be
      undetected. The investigator will study the safety of RVP, particularly for the heart and the
      brain, retrograde by studying troponin levels and magnetic resonance imaging or computed
      tomography.
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time
      during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood
      pressure which presents as an on-off phenomenon. The technique facilitates the dissection and
      manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be
      lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood
      pressure and clinical outcome were used as study parameters. However it is not clear whether
      repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral
      infarcts may be undetected if only clinical outcome is taken as a study parameter. In this
      retrograde study, the investigators will study the safety of RVP, particularly for the heart
      and the brain, using magnetic resonance imaging or computed tomography and troponin levels.
      The purpose of this study is to evaluate the effect of repetitive periods of RVP on the
      oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both
      markers for ischemia damage.
observational model: Case-Control
time perspective: Retrospective
measure: Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)
time frame: A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery
description: For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively
measure: Magnetic resonance imaging or computed tomography
time frame: Preoperative and within 1 week post surgery
description: Magnetic resonance imaging or computed tomography of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on)and fossa posterior will be evaluated.
arm group label: Cerebral aneurysm surgery with RVP
description: During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
arm group label: Craniotomy without RVP
description: No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
intervention type: Procedure
intervention name: Rapid ventricular pacing (RVP)
description: Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.
arm group label: Cerebral aneurysm surgery with RVP
intervention type: Procedure
intervention name: No rapid ventricular pacing
arm group label: Craniotomy without RVP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vera Saldien, MD
role: Principal Investigator
affiliation: University Hospital, Antwerp
last name: Tomas Menovsky, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Antwerp
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Joke De Wachter
investigator title: data manager
mesh term: Intracranial Aneurysm
mesh term: Intracranial Arteriovenous Malformations
mesh term: Aneurysm
mesh term: Arteriovenous Malformations