<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/NCT01728272</url>
  </required_header>
  <id_info>
    <org_study_id>KUH5101066</org_study_id>
    <nct_id>NCT01728272</nct_id>
  </id_info>
  <brief_title>Influence of CPB and Mini CPB to the Absorption of the Metoprolol</brief_title>
  <acronym>Minimeto</acronym>
  <official_title>Influence of CPB and Mini CPB to the Absorption of the Metoprolol After CABG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the&#xD;
      absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump&#xD;
      surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the&#xD;
      absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump&#xD;
      surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.&#xD;
&#xD;
      Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after&#xD;
      operation, before and 10 times after intake of 50 mg metoprolol.&#xD;
&#xD;
      Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>absorbtion of the metoprolol</measure>
    <time_frame>one year</time_frame>
    <description>absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation</measure>
    <time_frame>one year</time_frame>
    <description>is there correlation of incidence of the postopeative AF and absorbtion of the metoprolol</description>
  </secondary_outcome>
  <other_outcome>
    <measure>recovery from rocedure</measure>
    <time_frame>one year</time_frame>
    <description>How does gereral recovery correlate between randomized groups</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Drug Absorption</condition>
  <arm_group>
    <arm_group_label>blood concentration of metoprolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>how does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>blood concentration of metoprolol</intervention_name>
    <description>measure blood concentration of metoprolol</description>
    <arm_group_label>blood concentration of metoprolol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: elective CABG patient -&#xD;
&#xD;
        Exclusion Criteria: contraindication to metoprolol&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <zip>70100</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Maaroos, MD</last_name>
      <phone>358400218801</phone>
      <email>martin.maaroos@kuh.fi</email>
    </contact>
    <investigator>
      <last_name>Martin Maaroos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>August 19, 2015</last_update_submitted>
  <last_update_submitted_qc>August 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metoprolol, atrial fibrillation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoprolol</mesh_term>
  </intervention_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/NCT01728272
org study id: KUH5101066
nct id: NCT01728272
lead sponsor: 
has dmc: Yes
Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the
      absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump
      surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.
Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the
      absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump
      surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

      Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after
      operation, before and 10 times after intake of 50 mg metoprolol.

      Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: absorbtion of the metoprolol
time frame: one year
description: absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed
measure: atrial fibrillation
time frame: one year
description: is there correlation of incidence of the postopeative AF and absorbtion of the metoprolol
measure: recovery from rocedure
time frame: one year
description: How does gereral recovery correlate between randomized groups
arm group label: blood concentration of metoprolol
arm group type: Experimental
description: how does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG
intervention type: Drug
intervention name: blood concentration of metoprolol
description: measure blood concentration of metoprolol
arm group label: blood concentration of metoprolol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Finland
responsible party type: Sponsor
mesh term: Metoprolol