<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/NCT03038360</url>
  </required_header>
  <id_info>
    <org_study_id>ST0033</org_study_id>
    <nct_id>NCT03038360</nct_id>
  </id_info>
  <brief_title>Prospective Study With AMI Patients Undergoing PCI</brief_title>
  <acronym>CardioSAVE</acronym>
  <official_title>CardioSAVE: A 12-months Prospective Longitudinal Controlled Study for the Validation of a Novel Predictive Model and a Diagnostic Tool, for the Risk Stratification of AMI Patients Undergoing PCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Firalis SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herz-Zentrums Bad Krozingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Firalis SA</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>
      CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a&#xD;
      novel predictive model and a diagnostic tool, for the risk stratification of AMI patients&#xD;
      undergoing PCI, with a one year follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study rational:&#xD;
&#xD;
      Acute Myocardial Infarction (AMI), a common manifestation of coronary artery disease (CAD),&#xD;
      is associated with a relatively high incidence and fatality rate. Myocardial Infarction (MI),&#xD;
      commonly known as &quot;heart attack&quot;, which usually results from an impaired blood supply often&#xD;
      caused by thrombus formation in a coronary vessel, resulting in an acute reduction of oxygen&#xD;
      supply to a portion of the myocardium. Reperfusion using primary angioplasty through&#xD;
      percutaneous coronary intervention (PCI) was proven to be superior to other methods in&#xD;
      reducing the fatality rate of the acute phase of the AMI.&#xD;
&#xD;
      During the last decade tremendous efforts have been given to the identification of cardiac&#xD;
      biomarkers (BMs) for the diagnosis of AMI. Cardiac BMs have been proven extremely useful in&#xD;
      facilitating the diagnostic as well as the timing of therapeutic intervention and in&#xD;
      addressing important questions in terms of physiopathology . This resulted in the extensive&#xD;
      use of BMs such as troponins in the diagnosis of MI.&#xD;
&#xD;
      Firalis and the Luxembourg general hospital have identified novel biomarkers that could serve&#xD;
      as independent risk predictors and prognostic markers for cardiac and clinical complications.&#xD;
      First to confirm the value of our identified biomarker panels and to increase their&#xD;
      diagnostic/predictive performance, Firalis will identify novel BMs in patient undergoing PCI&#xD;
      to include novel biomarkers in this panel and develop a novel early stage prognostic test for&#xD;
      clinical outcome in acute myocardial infarction (AMI) patients receiving percutaneous&#xD;
      coronary intervention (PCI). This novel test will also be able to monitor treatment response.&#xD;
&#xD;
      For this purpose, the predictive and diagnostic value of the candidate biomarker set have to&#xD;
      be clinically validated in a controlled prospective study conducted by the Bad Krozingen&#xD;
      Hearth Center. The sample and data collected in this proof of concept study will constitute&#xD;
      an independent validation set at the Bad Krozingen Heart Center. Early time point samples&#xD;
      will be used to estimate the risk associated with patients and the data obtained will be&#xD;
      correlated with the one year outcome of patients.&#xD;
&#xD;
      The development and successful implementation of such diagnostic assay will have strong&#xD;
      impact on the quality of care AMI patients, and will significantly reduce costs for&#xD;
      healthcare and economy.&#xD;
&#xD;
      Primary objectives:&#xD;
&#xD;
        -  To monitor clinical complications registered following PCI, e.g. death, re-infarction&#xD;
           and heart failure&#xD;
&#xD;
        -  To perform cardiac measurements including electrocardiogram, and left ventricular&#xD;
           ejection fraction (LVEF) by cardiac echography and post-AMI myocardium remodelling by&#xD;
           cardiac magnetic resonance (CMR) imaging&#xD;
&#xD;
        -  To determine the levels of new and exploratory biomarkers in peripheral blood samples&#xD;
           collected before and 1 to 3 days after PCI in patients with MI and to correlate them&#xD;
           with clinical outcomes.&#xD;
&#xD;
        -  To assess the prognostic and diagnostic values of each biomarker or combination of&#xD;
           biomarkers prior and shortly (3 and 5 days) after PCI treatment long-term (12 months)&#xD;
           clinical outcomes.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To quantitatively measure reference biomarkers related to cardiac function, including&#xD;
           Troponin I/T, CK, CK-MB, BNP, NT-proBNP.&#xD;
&#xD;
        -  To correlate the levels of new and exploratory biomarkers with reference biomarkers&#xD;
           (Troponin I/T, CK, CK-MB, NT-Pro BNP) and cardiac measurements including&#xD;
           electrocardiogram, post-AMI myocardium remodelling by magnetic resonance imaging, and&#xD;
           left ventricular ejection fraction (LVEF) by cardiac echography.&#xD;
&#xD;
        -  To evaluate the prognostic and diagnostic values of each biomarker or combination with&#xD;
           regard to reference biomarkers (Troponin I/T, CK, CK-MB, NT-Pro BNP) as well as the&#xD;
           combination of new and reference biomarkers against classical reference biomarkers, and&#xD;
           cardiac measurements including regression of ST-segment by electrocardiogram, post-AMI&#xD;
           myocardium remodelling by magnetic resonance imaging, and left ventricular ejection&#xD;
           fraction (LVEF) by cardiac echography.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      CardioSAVE is a prospective 12-month controlled longitudinal study in 600 AMI patients, with&#xD;
      a one year follow-up conducted by the Bad Krozingen Heart Center. The objectif is to validate&#xD;
      a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients&#xD;
      undergoing PCI. The sample and data collected by eCRF will allow to set up a prototype&#xD;
      personalized medicine device focusing on Heart Failure (HF) induced by AMI. The primary&#xD;
      endpoint will be the proportion of patients with left ventricular ejection fraction (LVEF) &lt;&#xD;
      40% at 6 months. The main secondary endpoint is recovery of regional wall motion measured by&#xD;
      cMRI at 6 months. Early time point samples, cMRI at day 3 and other clinical patient data&#xD;
      will be used to estimate the risk associated with patients and the data obtained will be&#xD;
      correlated with the one year outcome of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2014</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Left Ventricular Ejection Fraction (LVEF) &lt; 40%</measure>
    <time_frame>At 6 months after PCI</time_frame>
    <description>Proportion of patients with LV-EF &lt; 40% at 6 months or Death and/or occurence of serious cardiovascular events such as reinfarction, onset of a cardiovascular disease (e.g. heart failure).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recovery of regional wall motion</measure>
    <time_frame>At 6 months after PCI</time_frame>
    <description>Recovery of regional wall motion measured by cMRI at 6 months</description>
  </secondary_outcome>
  <enrollment type="Actual">620</enrollment>
  <condition>Heart Failure</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention&#xD;
        (PCI)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and Female patients with non childbearing potential (post-menopausal,&#xD;
             ovariectomised or hysterectomised) patients. Menopause is defined as &gt; 60 years, or&#xD;
             between 45 and 60 years being amenorrheic for at least 2 years&#xD;
&#xD;
          2. Age more than 18 years old&#xD;
&#xD;
          3. Acute myocardial infarction with clinical decision to treat with percutaneous coronary&#xD;
             intervention&#xD;
&#xD;
             Primary PCI for myocardial infarction:&#xD;
&#xD;
               -  ST-elevation myocardial infarction (STEMI) or&#xD;
&#xD;
               -  Large non-ST-elevation myocardial infarction (NSTEMI) with hs-Troponin T ≥ 0,1&#xD;
                  ng/mL&#xD;
&#xD;
          4. Having signed an Informed Consent to participate in the trial before any study related&#xD;
             procedure has been taken.&#xD;
&#xD;
          5. Having signed an Informed Consent for Biobank sampling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous&#xD;
        AMI, angina within 48h before infarction, previous CABG 3. Severe concomitant non-cardiac&#xD;
        illnesses 4. Relevant non-coronary cardiac illnesses 5. Planned major surgery 6.&#xD;
        Participated in any investigational drug or therapy study with a non-approved medication,&#xD;
        within the previous 3 months 7. Being - dependent on the Investigator or the Sponsor (e.g.,&#xD;
        including but not limited to affiliated employee)&#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>Hueseyin Firat, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Firalis SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitaets Herz Zentrum</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>May 20, 2023</last_update_submitted>
  <last_update_submitted_qc>May 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</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>Heart Failure</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/NCT03038360
org study id: ST0033
nct id: NCT03038360
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a
      novel predictive model and a diagnostic tool, for the risk stratification of AMI patients
      undergoing PCI, with a one year follow-up.
Study rational:

      Acute Myocardial Infarction (AMI), a common manifestation of coronary artery disease (CAD),
      is associated with a relatively high incidence and fatality rate. Myocardial Infarction (MI),
      commonly known as "heart attack", which usually results from an impaired blood supply often
      caused by thrombus formation in a coronary vessel, resulting in an acute reduction of oxygen
      supply to a portion of the myocardium. Reperfusion using primary angioplasty through
      percutaneous coronary intervention (PCI) was proven to be superior to other methods in
      reducing the fatality rate of the acute phase of the AMI.

      During the last decade tremendous efforts have been given to the identification of cardiac
      biomarkers (BMs) for the diagnosis of AMI. Cardiac BMs have been proven extremely useful in
      facilitating the diagnostic as well as the timing of therapeutic intervention and in
      addressing important questions in terms of physiopathology . This resulted in the extensive
      use of BMs such as troponins in the diagnosis of MI.

      Firalis and the Luxembourg general hospital have identified novel biomarkers that could serve
      as independent risk predictors and prognostic markers for cardiac and clinical complications.
      First to confirm the value of our identified biomarker panels and to increase their
      diagnostic/predictive performance, Firalis will identify novel BMs in patient undergoing PCI
      to include novel biomarkers in this panel and develop a novel early stage prognostic test for
      clinical outcome in acute myocardial infarction (AMI) patients receiving percutaneous
      coronary intervention (PCI). This novel test will also be able to monitor treatment response.

      For this purpose, the predictive and diagnostic value of the candidate biomarker set have to
      be clinically validated in a controlled prospective study conducted by the Bad Krozingen
      Hearth Center. The sample and data collected in this proof of concept study will constitute
      an independent validation set at the Bad Krozingen Heart Center. Early time point samples
      will be used to estimate the risk associated with patients and the data obtained will be
      correlated with the one year outcome of patients.

      The development and successful implementation of such diagnostic assay will have strong
      impact on the quality of care AMI patients, and will significantly reduce costs for
      healthcare and economy.

      Primary objectives:

        -  To monitor clinical complications registered following PCI, e.g. death, re-infarction
           and heart failure

        -  To perform cardiac measurements including electrocardiogram, and left ventricular
           ejection fraction (LVEF) by cardiac echography and post-AMI myocardium remodelling by
           cardiac magnetic resonance (CMR) imaging

        -  To determine the levels of new and exploratory biomarkers in peripheral blood samples
           collected before and 1 to 3 days after PCI in patients with MI and to correlate them
           with clinical outcomes.

        -  To assess the prognostic and diagnostic values of each biomarker or combination of
           biomarkers prior and shortly (3 and 5 days) after PCI treatment long-term (12 months)
           clinical outcomes.

      Secondary objectives:

        -  To quantitatively measure reference biomarkers related to cardiac function, including
           Troponin I/T, CK, CK-MB, BNP, NT-proBNP.

        -  To correlate the levels of new and exploratory biomarkers with reference biomarkers
           (Troponin I/T, CK, CK-MB, NT-Pro BNP) and cardiac measurements including
           electrocardiogram, post-AMI myocardium remodelling by magnetic resonance imaging, and
           left ventricular ejection fraction (LVEF) by cardiac echography.

        -  To evaluate the prognostic and diagnostic values of each biomarker or combination with
           regard to reference biomarkers (Troponin I/T, CK, CK-MB, NT-Pro BNP) as well as the
           combination of new and reference biomarkers against classical reference biomarkers, and
           cardiac measurements including regression of ST-segment by electrocardiogram, post-AMI
           myocardium remodelling by magnetic resonance imaging, and left ventricular ejection
           fraction (LVEF) by cardiac echography.

      Study design:

      CardioSAVE is a prospective 12-month controlled longitudinal study in 600 AMI patients, with
      a one year follow-up conducted by the Bad Krozingen Heart Center. The objectif is to validate
      a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients
      undergoing PCI. The sample and data collected by eCRF will allow to set up a prototype
      personalized medicine device focusing on Heart Failure (HF) induced by AMI. The primary
      endpoint will be the proportion of patients with left ventricular ejection fraction (LVEF) <
      40% at 6 months. The main secondary endpoint is recovery of regional wall motion measured by
      cMRI at 6 months. Early time point samples, cMRI at day 3 and other clinical patient data
      will be used to estimate the risk associated with patients and the data obtained will be
      correlated with the one year outcome of patients.
observational model: Cohort
time perspective: Prospective
measure: Left Ventricular Ejection Fraction (LVEF) < 40%
time frame: At 6 months after PCI
description: Proportion of patients with LV-EF < 40% at 6 months or Death and/or occurence of serious cardiovascular events such as reinfarction, onset of a cardiovascular disease (e.g. heart failure).
measure: Recovery of regional wall motion
time frame: At 6 months after PCI
description: Recovery of regional wall motion measured by cMRI at 6 months
Blood and urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hueseyin Firat, MD, PhD
role: Principal Investigator
affiliation: Firalis SA
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No