<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/NCT02248311</url>
  </required_header>
  <id_info>
    <org_study_id>PRECISED ISCiii-PIE-13</org_study_id>
    <nct_id>NCT02248311</nct_id>
  </id_info>
  <brief_title>&quot;Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population</brief_title>
  <acronym>PRECISED</acronym>
  <official_title>&quot;Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population: a Multidisciplinary Clinical and Experimental Approach&quot; (PRECISED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current methods based on traditional Cardiovascular risk factors are not clinically useful&#xD;
      for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic&#xD;
      events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in&#xD;
      Type 2 Diabetes population have worse prognosis than in general population. In fact, there is&#xD;
      sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects&#xD;
      of ischemic events and worsens their outcome.&#xD;
&#xD;
      A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes&#xD;
      patients. Therefore, new strategies aimed at identifying those patients with this subclinical&#xD;
      Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a&#xD;
      challenge to be met.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives&#xD;
&#xD;
      1) To examine whether the extension and degree of microangiopathy is an independent risk&#xD;
      factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and&#xD;
      extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate&#xD;
      whether a new score based on the extension and the degree of microangiopathy will permit us&#xD;
      to improve the current methods used to identify patients at risk of CVD and its outcomes. 4)&#xD;
      To determine whether the presence and the degree of NAFLD is an independent Cardiovascular&#xD;
      disease risk factor and represent and extra-value to the score based on the extension and the&#xD;
      degree of microangiopathy.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      1) To examine the usefulness of selected serum biomarkers in identifying diabetic patients at&#xD;
      risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related&#xD;
      to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3)&#xD;
      To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular&#xD;
      involvement vs. index of generalized endothelial dysfunction)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Subclinical Cardiovascular Diseases</measure>
    <time_frame>1 week</time_frame>
    <description>Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or &gt; 50% coronary artery stenosis (PET-SPECT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ischemic events</measure>
    <time_frame>3 years</time_frame>
    <description>Occurrence of Cardiovascular events during the 3 year follow up: Ictus, transient ischemic attack, acute coronary syndrome (STEMI or NSTEMI), angina, sudden cardiac death.&#xD;
Incidence of major adverse cardiovascular events at 30 days following acute ischemic syndrome (Death, Re-infarction, Ictus)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <condition>Microangiopathy</condition>
  <condition>Non Alcoholic Fatty Liver Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Cerebrovascular Disease</condition>
  <condition>Acute Coronary Syndrome/ Myocardial Infarction</condition>
  <condition>Ictus</condition>
  <arm_group>
    <arm_group_label>Patients/Control Group</arm_group_label>
    <description>Observational</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients/Group Control</arm_group_label>
    <description>Observational</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients: 200 Control group: 60&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 200 T2D diabetic patients without history of clinical Cardiovascular disease&#xD;
        will be recruited from the Outpatient Diabetic Clinic of Vall d'Hebron Hospital and the&#xD;
        Primary Health Care centers under its influence area. Sixty non-diabetic patients without&#xD;
        classic Cardiovascular risk factors matched by age will be used as a control group.&#xD;
        Specifically, vascular risk factors, concomitant diseases, family history of Cardiovascular&#xD;
        disease or stroke and the treatments taken at the time of inclusion will be collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a) Age from 50-79 years; b) History of type 2diabetes of at least one year. Diabetes&#xD;
             will be defined following the American Diabetic Association criteria: fasting glucose&#xD;
             level of at least 126 mg/dl [7.0 mmol/l] in two separate analyses, a non-fasting&#xD;
             glucose level of at least 200 mg/dl [11.1 mmol/l] or a self-reported history of&#xD;
             physician-diagnosed diabetes or treatment for diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a) Past medical history of Cardiovascular event; b) Type 1 diabetes; c)&#xD;
             Contraindication for PET-CT or MRI d) Other concomitant disease associated with a&#xD;
             short life expectancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David García-Dorado Garcia, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Montaner Vilallonga, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafael Simó Canonge, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Sayós Ortega, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Serón Micas, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Genescà Ferrer, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Santiago Aguadé Bruix, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Xavier Comella Carnicé, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Valle de Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Valle de Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_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/NCT02248311
org study id: PRECISED ISCiii-PIE-13
nct id: NCT02248311
lead sponsor: 
has dmc: No
Current methods based on traditional Cardiovascular risk factors are not clinically useful
      for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic
      events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in
      Type 2 Diabetes population have worse prognosis than in general population. In fact, there is
      sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects
      of ischemic events and worsens their outcome.

      A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes
      patients. Therefore, new strategies aimed at identifying those patients with this subclinical
      Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a
      challenge to be met.
Objectives

      1) To examine whether the extension and degree of microangiopathy is an independent risk
      factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and
      extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate
      whether a new score based on the extension and the degree of microangiopathy will permit us
      to improve the current methods used to identify patients at risk of CVD and its outcomes. 4)
      To determine whether the presence and the degree of NAFLD is an independent Cardiovascular
      disease risk factor and represent and extra-value to the score based on the extension and the
      degree of microangiopathy.

      Secondary objectives:

      1) To examine the usefulness of selected serum biomarkers in identifying diabetic patients at
      risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related
      to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3)
      To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular
      involvement vs. index of generalized endothelial dysfunction)
observational model: Case-Control
time perspective: Prospective
measure: Subclinical Cardiovascular Diseases
time frame: 1 week
description: Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or > 50% coronary artery stenosis (PET-SPECT)
measure: Ischemic events
time frame: 3 years
description: Occurrence of Cardiovascular events during the 3 year follow up: Ictus, transient ischemic attack, acute coronary syndrome (STEMI or NSTEMI), angina, sudden cardiac death.
Incidence of major adverse cardiovascular events at 30 days following acute ischemic syndrome (Death, Re-infarction, Ictus)
arm group label: Patients/Control Group
description: Observational
arm group label: Patients/Group Control
description: Observational
Patients: 200 Control group: 60
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David García-Dorado Garcia, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Joan Montaner Vilallonga, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Rafael Simó Canonge, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Joan Sayós Ortega, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Daniel Serón Micas, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Joan Genescà Ferrer, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Santiago Aguadé Bruix, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
last name: Joan Xavier Comella Carnicé, PhD MD
role: Principal Investigator
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Cerebrovascular Disorders
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Diabetes Mellitus, Type 2
mesh term: Infarction