<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/NCT01670838</url>
  </required_header>
  <id_info>
    <org_study_id>Kuopio UH</org_study_id>
    <nct_id>NCT01670838</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients</brief_title>
  <acronym>SAHHEART</acronym>
  <official_title>Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study investigating cardiac function and cardiac biomarkers in&#xD;
      patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to&#xD;
      document the incidence of myocardial dysfunction,to find the predictive factors of myocardial&#xD;
      dysfunction, describe heart rate variability and to assess the impact of all cardiac problems&#xD;
      on morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes,&#xD;
      leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium,&#xD;
      potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers,&#xD;
      remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are&#xD;
      taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene&#xD;
      sample is taken once on day one.&#xD;
&#xD;
      Primary outcome measurement is to document the incidence of myocardial dysfunction and the&#xD;
      predictive factors during the hospital stay and at three months.&#xD;
&#xD;
      Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality&#xD;
      during first three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Incidence of cardiac failure and the impact of cardiac problems on morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>The aims of the study are:&#xD;
to document the incidence of myocardial dysfunction&#xD;
to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors&#xD;
to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography&#xD;
to describe heart rate variability&#xD;
to assess the impact of all cardiac problems on morbidity</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">198</enrollment>
  <condition>Aneurysmal Subarachnoid Heamorrhage</condition>
  <condition>Nontraumatic Subarachnoid Haemorrhage</condition>
  <arm_group>
    <arm_group_label>subarachnoid haemorrhage</arm_group_label>
    <description>nontraumatic subarachnoid haemorrhage</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      MICRORNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study material consists of 200 consecutive aSAH-patients treated in Kuopio University&#xD;
        Hospital and Turku University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with nontraumatic subarachnoid haemorrhage&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Aneurysmal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Anticipated brain death &lt; 24 hours&#xD;
&#xD;
          -  Otherwise moribund patient&#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>Stepani Bendel, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>Senior consultant, intensivist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maarit Lång, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior consultant, intensivist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <zip>PL 1777</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>March 14, 2018</last_update_submitted>
  <last_update_submitted_qc>March 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuopio University Hospital</investigator_affiliation>
    <investigator_full_name>Maarit Lang</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>subarachnoid haemorrhage</keyword>
  <keyword>cardiopulmonary complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01670838
org study id: Kuopio UH
nct id: NCT01670838
lead sponsor: 
collaborator: 
has dmc: Yes
This is a prospective cohort study investigating cardiac function and cardiac biomarkers in
      patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to
      document the incidence of myocardial dysfunction,to find the predictive factors of myocardial
      dysfunction, describe heart rate variability and to assess the impact of all cardiac problems
      on morbidity and mortality.
Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes,
      leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium,
      potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers,
      remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are
      taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene
      sample is taken once on day one.

      Primary outcome measurement is to document the incidence of myocardial dysfunction and the
      predictive factors during the hospital stay and at three months.

      Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality
      during first three months.
observational model: Cohort
time perspective: Prospective
measure: Incidence of cardiac failure and the impact of cardiac problems on morbidity
time frame: 6 months
description: The aims of the study are:
to document the incidence of myocardial dysfunction
to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors
to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography
to describe heart rate variability
to assess the impact of all cardiac problems on morbidity
arm group label: subarachnoid haemorrhage
description: nontraumatic subarachnoid haemorrhage
MICRORNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stepani Bendel, PhD, MD
role: Study Director
affiliation: Senior consultant, intensivist
last name: Maarit Lång, MD
role: Principal Investigator
affiliation: Senior consultant, intensivist
facility: 
facility: 
facility: 
country: Finland
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Kuopio University Hospital
investigator full name: Maarit Lang
investigator title: MD
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
sharing ipd: No