<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/NCT04488536</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01708</org_study_id>
    <nct_id>NCT04488536</nct_id>
  </id_info>
  <brief_title>Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities</brief_title>
  <official_title>Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are&#xD;
      usually (&gt;90%) offered an early invasive strategy including coronary angiography possibly&#xD;
      followed by intervention, preferably percutaneous coronary intervention (PCI). Among non&#xD;
      ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only&#xD;
      approximately 40% receive an invasive approach in Sweden, since the majority are handled in a&#xD;
      conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological&#xD;
      treatment, there is a large variation between Swedish counties regarding the choice of&#xD;
      strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger&#xD;
      variation between acute hospitals ranging from 20% to 90 %.&#xD;
&#xD;
      The Swedish national guidelines for heart disease have emphasized that the patient's&#xD;
      biological age, i.e. the patient's biological status and expected length of life, is crucial&#xD;
      for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of&#xD;
      biological age, mixing co-morbidity, disability and cognitive impairment. The investigators&#xD;
      have previously reported the potential importance of frailty for short-term (1 month) and&#xD;
      medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of&#xD;
      frailty´s prognostic value, its capacity to predict adverse effects including complications,&#xD;
      and the potential to guide clinical decision-making for elderly patients with myocardial&#xD;
      infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of&#xD;
      comorbidity burden might influence rational decision-making.&#xD;
&#xD;
      Aims To explore the association between frailty and treatment patterns in cardiac care To&#xD;
      study the association between outcomes and degree of frailty, with and without comprehensive&#xD;
      adjustment for differences in baseline characteristics.&#xD;
&#xD;
      To study how treatment benefits for patients admitted to coronary care units differ in&#xD;
      patients depending on comorbidities and frailty.&#xD;
&#xD;
      Hypothesis The investigators hypothesize that frailty is independently associated with worse&#xD;
      outcomes, including mortality, readmissions and complications.&#xD;
&#xD;
      Methods and material An observational, register based, multicentre study. Inclusion criteria:&#xD;
      Patients consecutively included in the Swedish Web-System for Enhancement and Development of&#xD;
      Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies&#xD;
      (SWEDEHEART) registry. Exclusion criteria: None.&#xD;
&#xD;
      SWEDEHEART is a national quality registry collecting information on all patients hospitalized&#xD;
      with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with&#xD;
      data. Briefly, information is collected prospectively about individual patients' medical&#xD;
      history, treatment before admission, management during hospital stay, treatment at discharge,&#xD;
      and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register&#xD;
      per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.&#xD;
      However, as a pilot project to ensure feasibility, five hospitals began to register frailty&#xD;
      November 1st, 2017. For the investigators initial analyses data will be used from the pilot&#xD;
      study to assess the association between CFS level and outcomes. The data extraction will be&#xD;
      done by one of the monitors of the SWEDEHEART registry. After about two years the&#xD;
      investigators will extract data prospectively entered into the registry.&#xD;
&#xD;
      The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good&#xD;
      predictive validity and prognostic power, is relying on clinical judgment, and is relatively&#xD;
      easily used in clinical practice. Since the scale includes several degrees it can be&#xD;
      considered to be particularly appropriate for risk stratification, and accordingly it has&#xD;
      been used for this purpose. The investigators have got the instrument owner´s permission to&#xD;
      use this scale.&#xD;
&#xD;
      The case record form (CRF) focus on demographic and clinical patient characteristics&#xD;
      registered in the SWEDEHEART, particularly those which are supposed to be potential&#xD;
      confounders when testing the hypothesis: chronological age, gender, cardiovascular risk,&#xD;
      diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson&#xD;
      Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification&#xD;
      of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute&#xD;
      Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory&#xD;
      testing and registration of anthropometric data will be included according to routine&#xD;
      practice within the frame of SWEDEHEART.&#xD;
&#xD;
      Follow-up of cohorts of invasively or conservatively treated patients with different stages&#xD;
      of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point&#xD;
      respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background In Western countries the numbers of elderly patients are increasing. Although many&#xD;
      elderly individuals are healthy, the number of individuals with complex needs for health care&#xD;
      is large and growing. Patients less than 80 years of age, who suffer a myocardial infarction&#xD;
      are usually offered an early invasive strategy including coronary angiography possibly&#xD;
      followed by intervention, preferably percutaneous coronary intervention (PCI). Among non&#xD;
      ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only&#xD;
      approximately 40% receive an invasive approach in Sweden, since the majority are handled in a&#xD;
      conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological&#xD;
      treatment, there is a large variation between Swedish counties regarding the choice of&#xD;
      strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger&#xD;
      variation between acute hospitals ranging from 20% to 90 %.&#xD;
&#xD;
      The Swedish national guidelines for heart disease have emphasized that the patient's&#xD;
      biological age, i.e. the patient's biological status and expected length of life, is crucial&#xD;
      for decision-making, though there is limited guidance regarding how the biological age should&#xD;
      be estimated.The term frailty denotes a multi-dimensional syndrome characterized by increased&#xD;
      vulnerability and decreased physiologic reserves, which can be seen as a marker of biological&#xD;
      age.&#xD;
&#xD;
      The Canadian Study of Health and Ageing (CSHA) Clinical Frailty Scale (CFS) is a global&#xD;
      clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment.&#xD;
      The CFS might be the most commonly used frailty instrument in an acute care context. The&#xD;
      investigators have previously reported the potential importance of frailty for short-term (1&#xD;
      month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on&#xD;
      the role of frailty´s prognostic value, its capacity to predict adverse effects including&#xD;
      complications, and the potential to guide clinical decision-making for elderly patients with&#xD;
      myocardial infarction are scarce, particularly regarding longer-term outcomes.Similarly,&#xD;
      there is a lack of knowledge of how different patterns of comorbidity burden, e.g. measured&#xD;
      by a well-established index like the Charlson Comorbidity Index (CCI) might influence&#xD;
      rational decision-making. Particularly this might be true regarding the combination of&#xD;
      frailty and comorbidity.&#xD;
&#xD;
      The large variation in the management of these patients shows that there is need for further&#xD;
      studies within this area in order to determine which treatment one should chose, whether it&#xD;
      be invasive or conservative, in different groups.&#xD;
&#xD;
      Aims To explore the association between frailty and treatment patterns in cardiac care To&#xD;
      study the association between outcomes and degree of frailty, with and without comprehensive&#xD;
      adjustment for differences in baseline characteristics.&#xD;
&#xD;
      To study how treatment benefits for patients admitted to coronary care units differ in&#xD;
      patients depending on comorbidities and frailty.&#xD;
&#xD;
      Hypothesis The investigators hypothesize that frailty is independently associated with worse&#xD;
      outcomes, including mortality, readmissions and complications.&#xD;
&#xD;
      The investigators also hypothesize that frailty influences the benefit-risk ratio for&#xD;
      pharmacological therapies and invasive treatments.&#xD;
&#xD;
      Methods and material An observational, register based, multicentre study. Inclusion criteria:&#xD;
      Patients consecutively included in the SWEDEHEART registry. Exclusion criteria: None.&#xD;
&#xD;
      SWEDEHEART is a national quality registry collecting information on all patients hospitalized&#xD;
      with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with&#xD;
      data. Briefly, information is collected prospectively about individual patients' medical&#xD;
      history, treatment before admission, management during hospital stay, treatment at discharge,&#xD;
      and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register&#xD;
      per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.&#xD;
      However, as a pilot project to ensure feasibility, five hospitals began to register frailty&#xD;
      November 1st, 2017. These include three university hospitals: the Huddinge-Karolinska&#xD;
      Hospital, the Linköping University Hospital and the Sahlgrenska Hospital, and two large&#xD;
      county hospitals: The NAL-Uddevalla (NU) Hospital and Gavle Hospital. For the investigators&#xD;
      initial analyses data will be used from the pilot study to assess the association between CFS&#xD;
      level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART&#xD;
      registry. After about two years the investigators will extract data prospectively entered&#xD;
      into the registry. By use of the Swedish unique personal identification numbers (PIN) data&#xD;
      from the SWEDEHAERT will be merged with data from the National cause of death registry in&#xD;
      order to obtain information on mortality and cause of death, with the National patient&#xD;
      registry, a comprehensive national register of the consumption of inpatient hospital care&#xD;
      maintained by the Swedish National Board of Health and Welfare, to obtain information on&#xD;
      comorbidity and outcomes, with the Swedish prescribed drugs registry to obtain information on&#xD;
      collected drugs and from Statistics Sweden information on socio-economic factors and country&#xD;
      of birth. After data extraction, merging PINs will be removed and all statistical analyses&#xD;
      will be performed on de-identified data.&#xD;
&#xD;
      The frailty instrument The crucial study instrument CFS is a 9-point scale, derived from the&#xD;
      deficit of accumulation model of frailty, and it has been validated against the Frailty&#xD;
      Index. It has good predictive validity and prognostic power, is relying on clinical judgment,&#xD;
      and is relatively easily used in clinical practice, see the attached document Clinical&#xD;
      Frailty Scale. Since the scale includes several degrees it can be considered to be&#xD;
      particularly appropriate for risk stratification, and accordingly it has been used for this&#xD;
      purpose. The investigators have got the instrument owner´s permission to use this scale.&#xD;
&#xD;
      The evaluation of the patient's degree of frailty will be based on bedside judgment&#xD;
      undertaken preferably by registered nurses regarding frailty and other clinical information&#xD;
      including the records in the patient file. The inter-rater reliability among a sample of&#xD;
      frailty-assessing nurses will be pragmatically assessed before the study start, see&#xD;
      Statistics. During the study there will be several support functions in order to enhance the&#xD;
      validity and reliability of the judgments: a manual and an instruction film on the frailty&#xD;
      assessment via CFS has been developed by a focus group including cardiological and geriatric&#xD;
      expertise; there will be instructions on how to assess frailty on the homepage of SWEDEHEART;&#xD;
      and five trained SWEDEHEART nurses will function as monitors and support for the local&#xD;
      assessing nurses, as will the mentioned expert group.&#xD;
&#xD;
      The CRF focus on demographic and clinical patient characteristics registered in the&#xD;
      SWEDEHEART, particularly those which are supposed to be potential confounders when testing&#xD;
      the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure,&#xD;
      renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI),&#xD;
      previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular&#xD;
      risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk&#xD;
      score (GRS).&#xD;
&#xD;
      Results from echocardiography, ECGs, laboratory testing and registration of anthropometric&#xD;
      data will be included according to routine practice within the frame of SWEDEHEART.&#xD;
&#xD;
      Follow-up of cohorts of invasively or conservatively treated patients with different stages&#xD;
      of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point&#xD;
      respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Mortality rate by 6 months after inclusion.</measure>
    <time_frame>6 months after inclusion</time_frame>
    <description>Mortality rate (death from any cause) by 6 months after inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rates up to 36 months after inclusion.</measure>
    <time_frame>3-36 months after inclusion</time_frame>
    <description>Mortality rates (death from any cause) up to 36 months after inclusion (measured at 3, 12, 24, 36 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of readmissions and complications up to 36 months after inclusion.</measure>
    <time_frame>3-36 months after inclusion</time_frame>
    <description>Rates of readmissions, re-infarctions, major bleedings and other complications up to 36 months after inclusion (measured at 3, 12, 24, 36 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of treatment patterns including medications and invasive strategies from admission to hospital (inclusion) to discharge from hospital (index care hospital episode)</measure>
    <time_frame>From admission to hospital (inclusion) up to 36 months after inclusion</time_frame>
    <description>Percentage (%) of patients receiving evidence based medications during the index care hospital episode Percentage (%) of patients receiving evidence based interventions during the index care hospital episode</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Frail patients</arm_group_label>
    <description>Clinical Frailty Scale level 5-9</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonfrail patients</arm_group_label>
    <description>Clinical Frailty Scale level 1-4</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Clinical Frailty Scale</intervention_name>
    <description>Frailty assessment</description>
    <arm_group_label>Frail patients</arm_group_label>
    <arm_group_label>Nonfrail patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        SWEDEHEART is a national quality registry, which collects information on all patients&#xD;
        hospitalized with MI or suspected MI. All 72 Swedish hospitals with acute coronary care&#xD;
        contribute with data. From January 1st 2020 Clinical Frailty Scale, the 9-degree-version&#xD;
        (CFS-9) is a mandatory variable in the registry. However, as a pilot project to ensure&#xD;
        feasibility, five hospitals began to register frailty November 1st, 2017. Inclusion&#xD;
        criteria: patients consecutively included in the SWEDEHEART registry from November 1, 2017.&#xD;
        Exklusion criteria: none.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients consecutively included in the SWEDEHEART registry from November 1, 2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niklas Ekerstad, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Center for Medical Technology Assessment/IMH, Linkoeping University</name>
      <address>
        <city>Linköping</city>
        <state>Oestergoetland</state>
        <zip>58183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkoeping University Hospital</name>
      <address>
        <city>Linköping</city>
        <state>Ostergoetland</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Niklas Ekerstad</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>Frailty assessment</keyword>
  <keyword>Clinical Frailty Scale</keyword>
  <keyword>Predictive power</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Frailty</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/NCT04488536
org study id: 2020-01708
nct id: NCT04488536
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are
      usually (>90%) offered an early invasive strategy including coronary angiography possibly
      followed by intervention, preferably percutaneous coronary intervention (PCI). Among non
      ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only
      approximately 40% receive an invasive approach in Sweden, since the majority are handled in a
      conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological
      treatment, there is a large variation between Swedish counties regarding the choice of
      strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger
      variation between acute hospitals ranging from 20% to 90 %.

      The Swedish national guidelines for heart disease have emphasized that the patient's
      biological age, i.e. the patient's biological status and expected length of life, is crucial
      for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of
      biological age, mixing co-morbidity, disability and cognitive impairment. The investigators
      have previously reported the potential importance of frailty for short-term (1 month) and
      medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of
      frailty´s prognostic value, its capacity to predict adverse effects including complications,
      and the potential to guide clinical decision-making for elderly patients with myocardial
      infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of
      comorbidity burden might influence rational decision-making.

      Aims To explore the association between frailty and treatment patterns in cardiac care To
      study the association between outcomes and degree of frailty, with and without comprehensive
      adjustment for differences in baseline characteristics.

      To study how treatment benefits for patients admitted to coronary care units differ in
      patients depending on comorbidities and frailty.

      Hypothesis The investigators hypothesize that frailty is independently associated with worse
      outcomes, including mortality, readmissions and complications.

      Methods and material An observational, register based, multicentre study. Inclusion criteria:
      Patients consecutively included in the Swedish Web-System for Enhancement and Development of
      Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies
      (SWEDEHEART) registry. Exclusion criteria: None.

      SWEDEHEART is a national quality registry collecting information on all patients hospitalized
      with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with
      data. Briefly, information is collected prospectively about individual patients' medical
      history, treatment before admission, management during hospital stay, treatment at discharge,
      and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register
      per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.
      However, as a pilot project to ensure feasibility, five hospitals began to register frailty
      November 1st, 2017. For the investigators initial analyses data will be used from the pilot
      study to assess the association between CFS level and outcomes. The data extraction will be
      done by one of the monitors of the SWEDEHEART registry. After about two years the
      investigators will extract data prospectively entered into the registry.

      The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good
      predictive validity and prognostic power, is relying on clinical judgment, and is relatively
      easily used in clinical practice. Since the scale includes several degrees it can be
      considered to be particularly appropriate for risk stratification, and accordingly it has
      been used for this purpose. The investigators have got the instrument owner´s permission to
      use this scale.

      The case record form (CRF) focus on demographic and clinical patient characteristics
      registered in the SWEDEHEART, particularly those which are supposed to be potential
      confounders when testing the hypothesis: chronological age, gender, cardiovascular risk,
      diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson
      Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification
      of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute
      Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory
      testing and registration of anthropometric data will be included according to routine
      practice within the frame of SWEDEHEART.

      Follow-up of cohorts of invasively or conservatively treated patients with different stages
      of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point
      respectively.
Background In Western countries the numbers of elderly patients are increasing. Although many
      elderly individuals are healthy, the number of individuals with complex needs for health care
      is large and growing. Patients less than 80 years of age, who suffer a myocardial infarction
      are usually offered an early invasive strategy including coronary angiography possibly
      followed by intervention, preferably percutaneous coronary intervention (PCI). Among non
      ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only
      approximately 40% receive an invasive approach in Sweden, since the majority are handled in a
      conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological
      treatment, there is a large variation between Swedish counties regarding the choice of
      strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger
      variation between acute hospitals ranging from 20% to 90 %.

      The Swedish national guidelines for heart disease have emphasized that the patient's
      biological age, i.e. the patient's biological status and expected length of life, is crucial
      for decision-making, though there is limited guidance regarding how the biological age should
      be estimated.The term frailty denotes a multi-dimensional syndrome characterized by increased
      vulnerability and decreased physiologic reserves, which can be seen as a marker of biological
      age.

      The Canadian Study of Health and Ageing (CSHA) Clinical Frailty Scale (CFS) is a global
      clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment.
      The CFS might be the most commonly used frailty instrument in an acute care context. The
      investigators have previously reported the potential importance of frailty for short-term (1
      month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on
      the role of frailty´s prognostic value, its capacity to predict adverse effects including
      complications, and the potential to guide clinical decision-making for elderly patients with
      myocardial infarction are scarce, particularly regarding longer-term outcomes.Similarly,
      there is a lack of knowledge of how different patterns of comorbidity burden, e.g. measured
      by a well-established index like the Charlson Comorbidity Index (CCI) might influence
      rational decision-making. Particularly this might be true regarding the combination of
      frailty and comorbidity.

      The large variation in the management of these patients shows that there is need for further
      studies within this area in order to determine which treatment one should chose, whether it
      be invasive or conservative, in different groups.

      Aims To explore the association between frailty and treatment patterns in cardiac care To
      study the association between outcomes and degree of frailty, with and without comprehensive
      adjustment for differences in baseline characteristics.

      To study how treatment benefits for patients admitted to coronary care units differ in
      patients depending on comorbidities and frailty.

      Hypothesis The investigators hypothesize that frailty is independently associated with worse
      outcomes, including mortality, readmissions and complications.

      The investigators also hypothesize that frailty influences the benefit-risk ratio for
      pharmacological therapies and invasive treatments.

      Methods and material An observational, register based, multicentre study. Inclusion criteria:
      Patients consecutively included in the SWEDEHEART registry. Exclusion criteria: None.

      SWEDEHEART is a national quality registry collecting information on all patients hospitalized
      with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with
      data. Briefly, information is collected prospectively about individual patients' medical
      history, treatment before admission, management during hospital stay, treatment at discharge,
      and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register
      per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.
      However, as a pilot project to ensure feasibility, five hospitals began to register frailty
      November 1st, 2017. These include three university hospitals: the Huddinge-Karolinska
      Hospital, the Linköping University Hospital and the Sahlgrenska Hospital, and two large
      county hospitals: The NAL-Uddevalla (NU) Hospital and Gavle Hospital. For the investigators
      initial analyses data will be used from the pilot study to assess the association between CFS
      level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART
      registry. After about two years the investigators will extract data prospectively entered
      into the registry. By use of the Swedish unique personal identification numbers (PIN) data
      from the SWEDEHAERT will be merged with data from the National cause of death registry in
      order to obtain information on mortality and cause of death, with the National patient
      registry, a comprehensive national register of the consumption of inpatient hospital care
      maintained by the Swedish National Board of Health and Welfare, to obtain information on
      comorbidity and outcomes, with the Swedish prescribed drugs registry to obtain information on
      collected drugs and from Statistics Sweden information on socio-economic factors and country
      of birth. After data extraction, merging PINs will be removed and all statistical analyses
      will be performed on de-identified data.

      The frailty instrument The crucial study instrument CFS is a 9-point scale, derived from the
      deficit of accumulation model of frailty, and it has been validated against the Frailty
      Index. It has good predictive validity and prognostic power, is relying on clinical judgment,
      and is relatively easily used in clinical practice, see the attached document Clinical
      Frailty Scale. Since the scale includes several degrees it can be considered to be
      particularly appropriate for risk stratification, and accordingly it has been used for this
      purpose. The investigators have got the instrument owner´s permission to use this scale.

      The evaluation of the patient's degree of frailty will be based on bedside judgment
      undertaken preferably by registered nurses regarding frailty and other clinical information
      including the records in the patient file. The inter-rater reliability among a sample of
      frailty-assessing nurses will be pragmatically assessed before the study start, see
      Statistics. During the study there will be several support functions in order to enhance the
      validity and reliability of the judgments: a manual and an instruction film on the frailty
      assessment via CFS has been developed by a focus group including cardiological and geriatric
      expertise; there will be instructions on how to assess frailty on the homepage of SWEDEHEART;
      and five trained SWEDEHEART nurses will function as monitors and support for the local
      assessing nurses, as will the mentioned expert group.

      The CRF focus on demographic and clinical patient characteristics registered in the
      SWEDEHEART, particularly those which are supposed to be potential confounders when testing
      the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure,
      renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI),
      previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular
      risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk
      score (GRS).

      Results from echocardiography, ECGs, laboratory testing and registration of anthropometric
      data will be included according to routine practice within the frame of SWEDEHEART.

      Follow-up of cohorts of invasively or conservatively treated patients with different stages
      of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point
      respectively.
observational model: Cohort
time perspective: Prospective
measure: Mortality rate by 6 months after inclusion.
time frame: 6 months after inclusion
description: Mortality rate (death from any cause) by 6 months after inclusion.
measure: Mortality rates up to 36 months after inclusion.
time frame: 3-36 months after inclusion
description: Mortality rates (death from any cause) up to 36 months after inclusion (measured at 3, 12, 24, 36 months)
measure: Rates of readmissions and complications up to 36 months after inclusion.
time frame: 3-36 months after inclusion
description: Rates of readmissions, re-infarctions, major bleedings and other complications up to 36 months after inclusion (measured at 3, 12, 24, 36 months)
measure: Description of treatment patterns including medications and invasive strategies from admission to hospital (inclusion) to discharge from hospital (index care hospital episode)
time frame: From admission to hospital (inclusion) up to 36 months after inclusion
description: Percentage (%) of patients receiving evidence based medications during the index care hospital episode Percentage (%) of patients receiving evidence based interventions during the index care hospital episode
arm group label: Frail patients
description: Clinical Frailty Scale level 5-9
arm group label: Nonfrail patients
description: Clinical Frailty Scale level 1-4
intervention type: Diagnostic Test
intervention name: Clinical Frailty Scale
description: Frailty assessment
arm group label: Frail patients
arm group label: Nonfrail patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Niklas Ekerstad, MD, PhD
role: Principal Investigator
affiliation: Linkoeping University
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Niklas Ekerstad
investigator title: Associate professor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Frailty
sharing ipd: No