<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/NCT03247049</url>
  </required_header>
  <id_info>
    <org_study_id>IDIAP Jordi Gol code P16/087</org_study_id>
    <nct_id>NCT03247049</nct_id>
  </id_info>
  <brief_title>Prognosis in Intracerebral Hemorrhage. The ICHCat Score in Primary Care.</brief_title>
  <acronym>ICHCat</acronym>
  <official_title>Predicting Long Term Survival in Patients With Primary Intracerebral Hemorrhage. Development and Validation of the ICHCat in Primary Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Miguel Hernandez de Elche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</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>
      The clinical evidence shows that patients with a first episode of intracerebral hemorrhage&#xD;
      (ICH) are increasingly old and with greater comorbidity with a recognized impact over&#xD;
      mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention&#xD;
      to identify those patients with favorable criteria that can benefit from possible treatments;&#xD;
      but also after hospital discharge, in primary care where the prediction should facilitate the&#xD;
      organization and management of a wide variety of resources: familiar, health and social&#xD;
      welfare. Even though there are different scales that predict mortality, these are not&#xD;
      sufficiently useful in choosing a treatment or do not provide sufficient data to the family&#xD;
      to decide.&#xD;
&#xD;
      Due to the characteristics of the population with ICH described in these works, it seems&#xD;
      useful to propose a prognostic index (ICHCat) to identify the variables associated to its&#xD;
      incidence and mortality and that, in addition, to make adjustments in the comparisons of the&#xD;
      survival between different series of patients or different treatment modalities in primary&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The authors carried out a multicentric and retrospective study of a cohort with an episode of&#xD;
      ICH in the period between 2006-2016. The objective of this phase is to design a predictive&#xD;
      index (ICHCat) of mortality in patients with an episode of ICH. Patient outcome was followed&#xD;
      until death all causes or study end (30.09.2016) since date of ICH in the electronic health&#xD;
      record. All people included were managed by the Public Health System in Catalonia. Registry&#xD;
      information was collected from the government-run healthcare provider responsible for all&#xD;
      inpatient care in the county.&#xD;
&#xD;
      Predictor Variables&#xD;
&#xD;
      Predictor variables were considered if they were viewed as commonly measured and available in&#xD;
      primary care and with potential evidence of an association with ICH risk. Candidate variables&#xD;
      included:&#xD;
&#xD;
      Sex: woman (0) man (1) Age: &lt;80 year-old (1), ≥80 year-old (2). Number CCP criteria: &lt;4 (0)&#xD;
      ≥4 (1). Charlson comorbidity index. Short version. Current medications were asked about&#xD;
      during the home visit and confirmed in medical records. Polypharmacy (defined as five or more&#xD;
      daily medications): &lt;5 (0), between 5-9 (1), and ≥10 (2). Oral anticoagulants (acenocumarol&#xD;
      or warfarin) with TTR ≥60% (1), if TRT &lt;60% (2) or New Oral Anticoagulants NOACs (0).&#xD;
      Antidepressants and/or, sedating or other drugs affecting the neurologic system: man (1),&#xD;
      woman (2). If there was a diagnostic of &quot;atrial fibrillation&quot;, CHA2DS2VASC and HAS-BLED&#xD;
      scores were included.&#xD;
&#xD;
      Recurrent falls or fall risk: no (0), yes (1). Hypertension not controlled by therapy (≥&#xD;
      160/90 mmHg): no (0), yes (1). BP was measured as an average of separated follow-up&#xD;
      measurements last six months.&#xD;
&#xD;
      Alcoholism abuse vs dependence: no (0), yes (1) Presence de cognitive impairment: a&#xD;
      disease-specific diagnosis of cognitive impairment and/or prescription of specific treatment,&#xD;
      without specification of sub-type or severity, was used and mesured by Pfeiffer test [2]:&#xD;
      [0-2 errors] = Intact Intellectual Functioning (1); [≥3 errors] = Mild to severe Intellectual&#xD;
      Impairment (2)].&#xD;
&#xD;
      Presence de disability: score in [Barthel ≥60 (1) &lt;60 (2)] or in [Rankin &lt;4 (1) 5(2)] were&#xD;
      used to assess dependence in ADL Functional status: (0) Autonomus (1) Residual with caretaker&#xD;
      (2) Dependence with caretaker (3) Long stay&#xD;
&#xD;
      Socio familiar risk: score in Gijon[18] scale 10-14 (1) ≥15 (2)]&#xD;
&#xD;
      Primary Outcome Given the limited survival, the primary outcome was death all causes&#xD;
      occurring within the 5-year follow-up after the ICH episode.&#xD;
&#xD;
      Predictions of ICH mortality risk were based on Cox proportional-hazards regression models.&#xD;
      All potential predictors were considered in a multivariate logistic regression, and a&#xD;
      backward step selection procedure was carried out to pick the variables that composed the&#xD;
      best model. Subsequently design a predictive model of multivariate Cox regression analysis to&#xD;
      define the weight of each of the pathologies in the mortality. To assign the weight according&#xD;
      to the value HR took into account only those with a HR ≥1.2 in the multivariate model&#xD;
      approximating the value of HR to the nearest whole number:&#xD;
&#xD;
        -  HR between 1.20 and 1.49 scored with 1.&#xD;
&#xD;
        -  HR between 1.50 and 2.49 with 2.&#xD;
&#xD;
        -  HR between 2.50 and 3.49 received 3, and so on.&#xD;
&#xD;
      The final score for each patient (ICH) was made up of the sum of their scores by age and&#xD;
      comorbidity. To check the validity of the index we define the following levels of mortality&#xD;
      risk:&#xD;
&#xD;
        -  Low risk: 0-1 points.&#xD;
&#xD;
        -  Medium Risk: from 2 to 5 points.&#xD;
&#xD;
        -  High Risk: of 6 or more points.&#xD;
&#xD;
      The authors estimate the survival probability of each risk group according to the&#xD;
      Kaplan-Meier method and compared these curves using the Log-Rank test. It will be used ROC&#xD;
      curves i the AUC to assess the ability of the index ICH to perform properly the assignment of&#xD;
      patients to different risk groups. The hazard ratio according to the proportional hazards&#xD;
      model categorized in their levels of risk, in order to observe the increase in the risk of&#xD;
      death that occurs from a risk group to the next. The statistical analysis consisted of a&#xD;
      multivariate logistic regression model. The model selection has been caried out with an&#xD;
      AIC-led forward step selection method. To ensure internal validity, 20% of data has been&#xD;
      discarded in the phase of constructing the model and only used to assess model performance&#xD;
      using ROC curves and the AUC.&#xD;
&#xD;
      In a second phase, there will be a retrospective study of validation in the cohort of&#xD;
      patients PCC of the territory with an episode of ICH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2015</start_date>
  <completion_date type="Actual">July 28, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Death all causes</measure>
    <time_frame>Within 5 years follow-up after episode ICH</time_frame>
    <description>Death all causes</description>
  </primary_outcome>
  <enrollment type="Actual">262</enrollment>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Outcome</condition>
  <condition>Survival</condition>
  <condition>Primary Care</condition>
  <condition>Hazard Risk</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort with an episode of ICH in the period April 1, 2006 to Setember 30, 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been suffered a Intracranial Hemorrhage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;15 and &gt;90 year-old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>V Francisco Gil-Guillen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Miguel Hernandez</affiliation>
  </overall_official>
  <results_reference>
    <citation>Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.</citation>
    <PMID>27113062</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 12, 2017</last_update_submitted>
  <last_update_submitted_qc>August 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</investigator_affiliation>
    <investigator_full_name>Josep Lluís Clua Espuny</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All IPD will be shared after definitive validation</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 10, 2022</submitted>
    <returned>July 11, 2023</returned>
  </pending_results>
  <!-- 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/NCT03247049
org study id: IDIAP Jordi Gol code P16/087
nct id: NCT03247049
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The clinical evidence shows that patients with a first episode of intracerebral hemorrhage
      (ICH) are increasingly old and with greater comorbidity with a recognized impact over
      mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention
      to identify those patients with favorable criteria that can benefit from possible treatments;
      but also after hospital discharge, in primary care where the prediction should facilitate the
      organization and management of a wide variety of resources: familiar, health and social
      welfare. Even though there are different scales that predict mortality, these are not
      sufficiently useful in choosing a treatment or do not provide sufficient data to the family
      to decide.

      Due to the characteristics of the population with ICH described in these works, it seems
      useful to propose a prognostic index (ICHCat) to identify the variables associated to its
      incidence and mortality and that, in addition, to make adjustments in the comparisons of the
      survival between different series of patients or different treatment modalities in primary
      care.
The authors carried out a multicentric and retrospective study of a cohort with an episode of
      ICH in the period between 2006-2016. The objective of this phase is to design a predictive
      index (ICHCat) of mortality in patients with an episode of ICH. Patient outcome was followed
      until death all causes or study end (30.09.2016) since date of ICH in the electronic health
      record. All people included were managed by the Public Health System in Catalonia. Registry
      information was collected from the government-run healthcare provider responsible for all
      inpatient care in the county.

      Predictor Variables

      Predictor variables were considered if they were viewed as commonly measured and available in
      primary care and with potential evidence of an association with ICH risk. Candidate variables
      included:

      Sex: woman (0) man (1) Age: <80 year-old (1), ≥80 year-old (2). Number CCP criteria: <4 (0)
      ≥4 (1). Charlson comorbidity index. Short version. Current medications were asked about
      during the home visit and confirmed in medical records. Polypharmacy (defined as five or more
      daily medications): <5 (0), between 5-9 (1), and ≥10 (2). Oral anticoagulants (acenocumarol
      or warfarin) with TTR ≥60% (1), if TRT <60% (2) or New Oral Anticoagulants NOACs (0).
      Antidepressants and/or, sedating or other drugs affecting the neurologic system: man (1),
      woman (2). If there was a diagnostic of "atrial fibrillation", CHA2DS2VASC and HAS-BLED
      scores were included.

      Recurrent falls or fall risk: no (0), yes (1). Hypertension not controlled by therapy (≥
      160/90 mmHg): no (0), yes (1). BP was measured as an average of separated follow-up
      measurements last six months.

      Alcoholism abuse vs dependence: no (0), yes (1) Presence de cognitive impairment: a
      disease-specific diagnosis of cognitive impairment and/or prescription of specific treatment,
      without specification of sub-type or severity, was used and mesured by Pfeiffer test [2]:
      [0-2 errors] = Intact Intellectual Functioning (1); [≥3 errors] = Mild to severe Intellectual
      Impairment (2)].

      Presence de disability: score in [Barthel ≥60 (1) <60 (2)] or in [Rankin <4 (1) 5(2)] were
      used to assess dependence in ADL Functional status: (0) Autonomus (1) Residual with caretaker
      (2) Dependence with caretaker (3) Long stay

      Socio familiar risk: score in Gijon[18] scale 10-14 (1) ≥15 (2)]

      Primary Outcome Given the limited survival, the primary outcome was death all causes
      occurring within the 5-year follow-up after the ICH episode.

      Predictions of ICH mortality risk were based on Cox proportional-hazards regression models.
      All potential predictors were considered in a multivariate logistic regression, and a
      backward step selection procedure was carried out to pick the variables that composed the
      best model. Subsequently design a predictive model of multivariate Cox regression analysis to
      define the weight of each of the pathologies in the mortality. To assign the weight according
      to the value HR took into account only those with a HR ≥1.2 in the multivariate model
      approximating the value of HR to the nearest whole number:

        -  HR between 1.20 and 1.49 scored with 1.

        -  HR between 1.50 and 2.49 with 2.

        -  HR between 2.50 and 3.49 received 3, and so on.

      The final score for each patient (ICH) was made up of the sum of their scores by age and
      comorbidity. To check the validity of the index we define the following levels of mortality
      risk:

        -  Low risk: 0-1 points.

        -  Medium Risk: from 2 to 5 points.

        -  High Risk: of 6 or more points.

      The authors estimate the survival probability of each risk group according to the
      Kaplan-Meier method and compared these curves using the Log-Rank test. It will be used ROC
      curves i the AUC to assess the ability of the index ICH to perform properly the assignment of
      patients to different risk groups. The hazard ratio according to the proportional hazards
      model categorized in their levels of risk, in order to observe the increase in the risk of
      death that occurs from a risk group to the next. The statistical analysis consisted of a
      multivariate logistic regression model. The model selection has been caried out with an
      AIC-led forward step selection method. To ensure internal validity, 20% of data has been
      discarded in the phase of constructing the model and only used to assess model performance
      using ROC curves and the AUC.

      In a second phase, there will be a retrospective study of validation in the cohort of
      patients PCC of the territory with an episode of ICH.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Death all causes
time frame: Within 5 years follow-up after episode ICH
description: Death all causes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: No
last name: V Francisco Gil-Guillen, PhD
role: Study Chair
affiliation: Universidad Miguel Hernandez
citation: Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
PMID: 27113062
responsible party type: Principal Investigator
investigator affiliation: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
investigator full name: Josep Lluís Clua Espuny
investigator title: PhD
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
sharing ipd: Undecided
ipd description: All IPD will be shared after definitive validation
submitted: August 10, 2022
returned: July 11, 2023