<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/NCT03837535</url>
  </required_header>
  <id_info>
    <org_study_id>Karolinska UH_PR</org_study_id>
    <nct_id>NCT03837535</nct_id>
  </id_info>
  <brief_title>Myocardial Infarction in the Perioperative Setting</brief_title>
  <acronym>MIPS</acronym>
  <official_title>Myocardial Infarction in the Perioperative Setting, a Swedish Multi Center Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</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>
      Acute myocardial infarction (AMI) is a significant complication following non-cardiac&#xD;
      surgery. The investigators sought to evaluate incidence of perioperative AMI, its&#xD;
      preoperative and intraoperative risk factors and the outcomes after this complication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      In Sweden, over 800 000 patients undergo surgery each year. Worldwide, the number of surgical&#xD;
      procedures yearly is over 310 million. Surgical care is an essential part of the advancement&#xD;
      in treating disease, associated with increased life expectancy and improved quality of life.&#xD;
      However, as surgical volume continues to grow, the number of patients who suffer&#xD;
      postoperative complications will also increase.&#xD;
&#xD;
      More specifically the project aims to answer the following questions:&#xD;
&#xD;
        1. How common is perioperative acute myocardial infarction following non-cardiac surgery?&#xD;
&#xD;
        2. What are the preoperative and intraoperative risk factors for peroperative AMI?&#xD;
&#xD;
        3. Does perioperative AMI affect mortality and morbidity, Length of stay and days at home?&#xD;
&#xD;
        4. Is the risk of AMI affected by the type of hospital, region or calendar year of surgery?&#xD;
&#xD;
      Orbit - surgical planning system:&#xD;
&#xD;
      The study population was identified from 23 hospitals of all levels (university-, County- and&#xD;
      district hospitals) in Sweden, that use the same software program to administer surgical&#xD;
      procedures, between 1999 and 2015. The Orbit surgical planning system obligatory includes&#xD;
      Swedish identity number, patient demographics, elective or non-elective status, date, type,&#xD;
      extent and duration of anesthesia and surgery. Information of the American Society of&#xD;
      Anesthesiologists (ASA) physical status classification was often available.&#xD;
&#xD;
      National Patient Register:&#xD;
&#xD;
      To obtain information on discharge dates, covariates and drug exposure, records of surgeries&#xD;
      will be linked to the national patient register using the unique Swedish personal&#xD;
      identification number assigned to all at birth or at immigration. The national registers have&#xD;
      close to complete coverage. The Swedish cause of death registry includes the deaths of all&#xD;
      Swedish citizens and residents with a national identity number; it is highly reliable with&#xD;
      over 99% of all deaths reported. The Swedish Prescribed Drug Register became operational in&#xD;
      July 2005 and contains data on all dispensed prescription of drugs in the Swedish population.&#xD;
&#xD;
      Swedeheart:&#xD;
&#xD;
      To identify all incident cases of myocardial infarctions, the surgical cohort will be linked&#xD;
      to Swedeheart, a National Quality Registry containing data on all patients with acute&#xD;
      myocardial infarction and all patients undergoing angiographic coronary intervention and&#xD;
      heart surgery. The Swedeheart registry was developed in January 1995 and has a present&#xD;
      coverage of 95% among incident cases of myocardial infarction treated at a cardiology&#xD;
      department.&#xD;
&#xD;
      The National Board of Health and Welfare:&#xD;
&#xD;
      The National Board of Health and Welfare publishes statistics in the areas of health and&#xD;
      medical care and social services, including data on acute myocardial infarction. The&#xD;
      statistics include all persons aged 20 years and above who have had an acute myocardial&#xD;
      infarction reported at the Hospital Discharge Register or the Cause of Death Register.&#xD;
      Statistics are presented by year, sex, age and geographical area, information of incidence&#xD;
      per 100 000 inhabitants is provided. These data were used to obtain information of expected&#xD;
      cases of MI, for standardized incidence ratios (SIR) to be calculated.&#xD;
&#xD;
      Study Participants:&#xD;
&#xD;
      Patients aged 18 years or older undergoing elective or non-elective inpatients surgery&#xD;
      between January 1, 2007 and December 31, 2014 were included. Exclusion criteria were&#xD;
      surgeries in ambulatory care, cardiac surgery, obstetric- and minor surgical procedures.&#xD;
      Patients were also excluded if the surgery was performed prior to 2007 or after 2014, and if&#xD;
      a valid surgery code in Orbit - or if a corresponding surgery code in NPR - was lacking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Acute Myocardial Infarction</measure>
    <time_frame>Within 30days of the index surgery</time_frame>
    <description>AMI, as detected in the postoperative phase in the electronic medical records or in the Swedeheart registry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within 30days of the index surgery and at later predefined time points: 60, 90, 180 and 365 days after the index surgery</time_frame>
    <description>Death, as detected in the postoperative phase in the Swedish cause of death register</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of stay (LOS)</measure>
    <time_frame>LOS within the year after the index surgery</time_frame>
    <description>Time spent in the hospital (number of days)</description>
  </other_outcome>
  <other_outcome>
    <measure>Days at home alive within 30 days (DAH30)</measure>
    <time_frame>DAH30 is counted within 30days of the index surgery</time_frame>
    <description>Time spent in the home after the index surgery, takes into account readmissions</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk of AMI and Mortality by gender, type of surgery, extent- and recency of comorbidity</measure>
    <time_frame>Within one year of the index surgery</time_frame>
    <description>How above mentioned patient characteristics affect risk of AMI and mortality</description>
  </other_outcome>
  <other_outcome>
    <measure>Secondary complications</measure>
    <time_frame>Secondary complications within one year of the index surgery</time_frame>
    <description>AMI vs non-AMI patients and their risk of AKI, pneumonia, stroke, infections, thromboembolic complications</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcomes (AMI+Mortality+Complications) by hospital, region and year</measure>
    <time_frame>All outcomes within one year of the index surgery</time_frame>
    <description>All outcomes as affected by hospital type, region and by year</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400742</enrollment>
  <condition>Myocardial Infarction Postoperative</condition>
  <condition>Myocardial Injury</condition>
  <condition>Intraoperative Complications</condition>
  <condition>Intraoperative Hypotension</condition>
  <condition>Peroperative Complication</condition>
  <arm_group>
    <arm_group_label>Patients undergoing surgery</arm_group_label>
    <description>Swedish patients, &gt;18 years undergoing surgery 2007-2014</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Neuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery</description>
    <arm_group_label>Patients undergoing surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing non-cardiac surgery between 2007 and 2014 in Swedish Hospitals&#xD;
        using the Orbit software surgical planning tool. This software system is used in all parts&#xD;
        of Sweden and in all types of hospitals (University, County and District hospitals)&#xD;
&#xD;
          -  University hospitals: Huddinge, KS, Norrlands universitetssjukhus, MAS, USIL, **&#xD;
             County hospitals: NU-sjukvården, Sundsvalls, Södra Älvsborgs, Örnsköldsviks ***&#xD;
             District hospitals: Helsingborgs lasarett, Hässleholms, Kristanstads, Kullbergska,&#xD;
             Landskrona, Lycksele, Mälarsjukhuset, Nyköping, Sollefteå, Skellefteå Södertälje,&#xD;
             Trelleborg, Ystad, Ängelholm, Privat Ortopedisk klinik&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (≥18 years), male and female&#xD;
&#xD;
          -  Undergoing elective or non-elective inpatient noncardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery&#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>Max Bell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital, Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Max Bell</investigator_full_name>
    <investigator_title>MD, PhD, Associate Professor, Senior Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Intraoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified cohort data for primary and secondary endpoints will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within a year of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access will be reviewed by an external research committee at the department of perioperative medicine and intensive care at the Karolinska University Hospital</ipd_access_criteria>
  </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/NCT03837535
org study id: Karolinska UH_PR
nct id: NCT03837535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute myocardial infarction (AMI) is a significant complication following non-cardiac
      surgery. The investigators sought to evaluate incidence of perioperative AMI, its
      preoperative and intraoperative risk factors and the outcomes after this complication.
Background:

      In Sweden, over 800 000 patients undergo surgery each year. Worldwide, the number of surgical
      procedures yearly is over 310 million. Surgical care is an essential part of the advancement
      in treating disease, associated with increased life expectancy and improved quality of life.
      However, as surgical volume continues to grow, the number of patients who suffer
      postoperative complications will also increase.

      More specifically the project aims to answer the following questions:

        1. How common is perioperative acute myocardial infarction following non-cardiac surgery?

        2. What are the preoperative and intraoperative risk factors for peroperative AMI?

        3. Does perioperative AMI affect mortality and morbidity, Length of stay and days at home?

        4. Is the risk of AMI affected by the type of hospital, region or calendar year of surgery?

      Orbit - surgical planning system:

      The study population was identified from 23 hospitals of all levels (university-, County- and
      district hospitals) in Sweden, that use the same software program to administer surgical
      procedures, between 1999 and 2015. The Orbit surgical planning system obligatory includes
      Swedish identity number, patient demographics, elective or non-elective status, date, type,
      extent and duration of anesthesia and surgery. Information of the American Society of
      Anesthesiologists (ASA) physical status classification was often available.

      National Patient Register:

      To obtain information on discharge dates, covariates and drug exposure, records of surgeries
      will be linked to the national patient register using the unique Swedish personal
      identification number assigned to all at birth or at immigration. The national registers have
      close to complete coverage. The Swedish cause of death registry includes the deaths of all
      Swedish citizens and residents with a national identity number; it is highly reliable with
      over 99% of all deaths reported. The Swedish Prescribed Drug Register became operational in
      July 2005 and contains data on all dispensed prescription of drugs in the Swedish population.

      Swedeheart:

      To identify all incident cases of myocardial infarctions, the surgical cohort will be linked
      to Swedeheart, a National Quality Registry containing data on all patients with acute
      myocardial infarction and all patients undergoing angiographic coronary intervention and
      heart surgery. The Swedeheart registry was developed in January 1995 and has a present
      coverage of 95% among incident cases of myocardial infarction treated at a cardiology
      department.

      The National Board of Health and Welfare:

      The National Board of Health and Welfare publishes statistics in the areas of health and
      medical care and social services, including data on acute myocardial infarction. The
      statistics include all persons aged 20 years and above who have had an acute myocardial
      infarction reported at the Hospital Discharge Register or the Cause of Death Register.
      Statistics are presented by year, sex, age and geographical area, information of incidence
      per 100 000 inhabitants is provided. These data were used to obtain information of expected
      cases of MI, for standardized incidence ratios (SIR) to be calculated.

      Study Participants:

      Patients aged 18 years or older undergoing elective or non-elective inpatients surgery
      between January 1, 2007 and December 31, 2014 were included. Exclusion criteria were
      surgeries in ambulatory care, cardiac surgery, obstetric- and minor surgical procedures.
      Patients were also excluded if the surgery was performed prior to 2007 or after 2014, and if
      a valid surgery code in Orbit - or if a corresponding surgery code in NPR - was lacking.
observational model: Cohort
time perspective: Prospective
measure: Acute Myocardial Infarction
time frame: Within 30days of the index surgery
description: AMI, as detected in the postoperative phase in the electronic medical records or in the Swedeheart registry
measure: Mortality
time frame: Within 30days of the index surgery and at later predefined time points: 60, 90, 180 and 365 days after the index surgery
description: Death, as detected in the postoperative phase in the Swedish cause of death register
measure: Length of stay (LOS)
time frame: LOS within the year after the index surgery
description: Time spent in the hospital (number of days)
measure: Days at home alive within 30 days (DAH30)
time frame: DAH30 is counted within 30days of the index surgery
description: Time spent in the home after the index surgery, takes into account readmissions
measure: Risk of AMI and Mortality by gender, type of surgery, extent- and recency of comorbidity
time frame: Within one year of the index surgery
description: How above mentioned patient characteristics affect risk of AMI and mortality
measure: Secondary complications
time frame: Secondary complications within one year of the index surgery
description: AMI vs non-AMI patients and their risk of AKI, pneumonia, stroke, infections, thromboembolic complications
measure: Outcomes (AMI+Mortality+Complications) by hospital, region and year
time frame: All outcomes within one year of the index surgery
description: All outcomes as affected by hospital type, region and by year
arm group label: Patients undergoing surgery
description: Swedish patients, >18 years undergoing surgery 2007-2014
intervention type: Procedure
intervention name: Surgery
description: Neuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery
arm group label: Patients undergoing surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Max Bell, MD, PhD
role: Principal Investigator
affiliation: Karolinska University Hospital, Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Max Bell
investigator title: MD, PhD, Associate Professor, Senior Lecturer
mesh term: Myocardial Infarction
mesh term: Hypotension
mesh term: Infarction
mesh term: Intraoperative Complications
sharing ipd: Yes
ipd description: De-identified cohort data for primary and secondary endpoints will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will be available within a year of study completion
ipd access criteria: Data access will be reviewed by an external research committee at the department of perioperative medicine and intensive care at the Karolinska University Hospital