<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/NCT03830944</url>
  </required_header>
  <id_info>
    <org_study_id>CM0119-VIA</org_study_id>
    <nct_id>NCT03830944</nct_id>
  </id_info>
  <brief_title>Inflammation-mediated Coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling</brief_title>
  <acronym>VIABILITY</acronym>
  <official_title>Impact of Inflammation-mediated Response on Pan-coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling in the Post-infarction Period - the VIABILITY Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardio Med Medical Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tîrgu Mureș Emergency Clinical County Hospital, Romania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardio Med Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      VIABILITY study aims to investigate the link between systemic inflammation, pancoronary&#xD;
      plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree),&#xD;
      myocardial viability and ventricular remodeling in patients who had suffered a recent&#xD;
      ST-segment elevation acute myocardial infarction (STEMI). The level of systemic inflammation&#xD;
      in the acute phase of the myocardial infarction and at 1 month will be assessed on the basis&#xD;
      of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteinases, interleukin-6).&#xD;
      Pancoronary plaque vulnerability will be assessed: (1) in the acute phase of the infarction,&#xD;
      based on serum biomarkers known to be associated with increased plaque vulnerability, such as&#xD;
      adhesion molecules (V-CAM or I-CAM) determined from the blood samples collected in the first&#xD;
      day after STEMI; (2) at 1 month after infarction, based on computed tomographic angiography&#xD;
      analysis of vulnerability features present in all coronary plaques. Myocardial viability and&#xD;
      remodeling will be assessed based on: (1) 3D speckle tracking echocardiography associated&#xD;
      with dobutamine infusion; (2) MRI imaging associated with complex post-processing techniques&#xD;
      for mapping myocardial fibrosis and scar at the level of left atrium and left ventricle. At&#xD;
      the same time, CT imaging features associated with systemic and local inflammation, such as&#xD;
      global epicardial fat or local pericoronary epicardial fat will be quantified in order to&#xD;
      investigate the impact of inflammatory-mediated plaque vulnerability on the extent of&#xD;
      myocardial damage in acute myocardial infarction. All these parameters will be investigated&#xD;
      in patients with successful primary revascularization performed in a timely manner for&#xD;
      ST-segment elevation acute myocardial infarction, who will be divided into 2 groups: group 1&#xD;
      - patients who present persistence of an augmented inflammatory status defined as serum&#xD;
      levels of hsCRP&gt;3.0 mg/dl at discharge from the hospital or at 7 days postinfarction&#xD;
      (whichever comes first), and group 2 - patients with no persistence of augmented inflammatory&#xD;
      status (hsCRP&lt;3.0 mg/dl).&#xD;
&#xD;
      The primary endpoint of the study will be represented by the rate of post-infarction heart&#xD;
      failure development, defined as the rate of re-admission in the hospital for heart failure or&#xD;
      by a significant decrease in the ejection fraction (&lt;45%).&#xD;
&#xD;
      The secondary endpoints of the study will be:&#xD;
&#xD;
        -  rate of re-hospitalization&#xD;
&#xD;
        -  rate of repeated revascularization&#xD;
&#xD;
        -  rate of major adverse cardiovascular events (MACE rate, including cardiovascular death&#xD;
           or stroke)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute myocardial infarction (AMI) who survive the acute event, very often&#xD;
      present a significant deterioration of their clinical status with progression towards heart&#xD;
      failure, which is directly linked to the extent of myocardial injury and the remodeling&#xD;
      process starting immediately after infarction. The major aim of the urgent revascularization&#xD;
      in STEMI is to save myocardial tissue from death and necrosis, in order to recover viable&#xD;
      myocardium. It is well-known that one of the major factors that trigger an AMI is the&#xD;
      systemic inflammation, which has a direct influence on coronary plaque vulnerability. At the&#xD;
      same time, 20% of patients surviving an AMI present a recurrent cardiovascular event in the&#xD;
      following 12 months, as a result of increased systemic inflammation triggered by the&#xD;
      infarction, which leads to vulnerabilization of other atheromatous plaques from all the&#xD;
      circulatory system in the post-infarction period. While the role of inflammation in acute&#xD;
      coronary events is well established, the impact of inflammatory-mediated vulnerability of&#xD;
      coronary plaques from the entire coronary tree on the extension of ventricular remodeling and&#xD;
      scaring has not been elucidated so far.&#xD;
&#xD;
      This is a clinical prospective, descriptive, single-center study which will be carried out in&#xD;
      the University of Medicine, Pharmacy, Science and Technology Tîrgu Mures, Romania, in&#xD;
      collaboration with two clinical sites: Center of Advanced Research in Multimodal Cardiac&#xD;
      Imaging Cardio Med Tîrgu Mures, Romania and County Clinical Emergency Hospital Tîrgu Mures,&#xD;
      Romania. The duration of the study is 2 years which includes the initial screening and the&#xD;
      follow-up period.&#xD;
&#xD;
      The study will enroll 100 subjects with STEMI who underwent successful revascularization of&#xD;
      the culprit lesion in the first 12 hours after the onset of symptoms. Imaging biomarkers and&#xD;
      laboratory analyses such as: high sensitive C Reactive Protein (hsCRP), matrix&#xD;
      metalloproteinases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide&#xD;
      (NT pro-BNP) will be determined in the first 24 hours after the index hospitalization. At 1&#xD;
      month postinfarction all patients will undergo Dobutamine stress test associated with speckle&#xD;
      tracking echocardiography for evaluation of myocardial function and viability, CMR for&#xD;
      assessment of myocardial scar, function and remodeling, and Multislice Angio CT for&#xD;
      assessment of pancoronary vulnerability, by complex characterization of vulnerability&#xD;
      features in all the coronary plaques present in the coronary tree. All these parameters will&#xD;
      be investigated in patients with successful primary percutaneous coronary revascularization,&#xD;
      who will be divided into 2 groups: group 1 -patients with persistent elevation of systemic&#xD;
      inflammatory biomarkers at discharge from the hospital or at day 7 (whichever comes first)&#xD;
      (inflammation+ group); and group 2 - patients with no persistent elevation of systemic&#xD;
      inflammatory biomarkers at discharge from the hospital or at day 7 (whichever comes first)&#xD;
      (inflammation- group). In all patients, the following biomarkers will be determined: serum&#xD;
      levels of inflammatory biomarkers, adhesion molecules and NT-proBNP at 24 hours and 7 days&#xD;
      post procedure, the amount of myocardial fibrosis and scar in the left ventricle at 1 month,&#xD;
      the degree of ventricular remodeling and myocardial perfusion at 1 month and the amount of&#xD;
      epicardial fat surrounding the heart and the plaques. The study will be conducted over a&#xD;
      period of 2 years, in which patients will be examined at baseline, and will be followed-up&#xD;
      for MACE incidence.&#xD;
&#xD;
      All patients will sign an informed written consent and will be checked for the exclusion&#xD;
      criteria prior to enrollment.&#xD;
&#xD;
      Study objectives:&#xD;
&#xD;
      Primary: To investigate the link between coronary inflammation-mediated plaque vulnerability,&#xD;
      myocardial viability and ventricular remodeling in the post-infarction period.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        -  To investigate the impact of systemic inflammation on structural remodeling of the left&#xD;
           ventricle in the post-infarction period&#xD;
&#xD;
        -  To investigate the impact of local inflammatory response on pancoronary plaque&#xD;
           vulnerability following an acute myocardial infarction.&#xD;
&#xD;
      Study Timeline:&#xD;
&#xD;
        -  Baseline - visit 1 (day 0)&#xD;
&#xD;
        -  Obtain and document consent from participant on study consent form.&#xD;
&#xD;
        -  Verify inclusion/exclusion criteria.&#xD;
&#xD;
        -  Obtain demographic information, medical history, medication history, alcohol and tobacco&#xD;
           use history.&#xD;
&#xD;
        -  Record results of physical examinations and 12-lead ECG.&#xD;
&#xD;
        -  Collect blood specimens (complete blood count, biochemistry, inflammatory biomarkers,&#xD;
           acute adhesion molecules).&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography/speckle tracking&#xD;
&#xD;
        -  Visit 2 (day 7 / discharge from the hospital)&#xD;
&#xD;
        -  -hsCRP&#xD;
&#xD;
        -  Visit 3 (month 1)&#xD;
&#xD;
        -  Coronary Computed Tomographic Angiography (vulnerability features, epicardial fat,&#xD;
           myocardial perfusion)&#xD;
&#xD;
        -  Cardiac Magnetic Resonance (myocardial fibrosis/scar, remodeling, viability)&#xD;
&#xD;
        -  Dobutamine stress echocardiography / speckle tracking (viability)&#xD;
&#xD;
        -  Visit 4,5,6 (month 3,6,9)&#xD;
&#xD;
        -  Record results of physical examinations, 12-lead ECG and medical history.&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography&#xD;
&#xD;
        -  Final study visit (month 12)&#xD;
&#xD;
        -  Record results of physical examinations, medical history,12-lead ECG&#xD;
&#xD;
        -  Imaging procedures: transthoracic 2-D echocardiography&#xD;
&#xD;
        -  End-point evaluation.&#xD;
&#xD;
      Study procedures:&#xD;
&#xD;
        -  Medical history, clinical examination, laboratory tests (complete blood count,&#xD;
           biochemistry, serum level of hs-CRP, MMP, IL6, NT-pro-BNP, adhesion molecules);&#xD;
&#xD;
        -  12-lead ECG&#xD;
&#xD;
        -  2D transthoracic echocardiography with measurement of: cardiac diameters, volumes, left&#xD;
           ventricular systolic and diastolic function, speckle tracking echo, dobutamine viability&#xD;
           test.&#xD;
&#xD;
        -  Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of&#xD;
           myocardial scar and fibrosis, ventricular function and remodeling index.&#xD;
&#xD;
        -  Angio Computed Tomography with assessment of coronary plaque vulnerability (based on&#xD;
           vulnerability features: positive remodeling, spotty calcification, napkin-ring sign, low&#xD;
           density plaque) and myocardial perfusion Data collection: All the information will be&#xD;
           collected in a database that consists of patient's background, medical history,&#xD;
           medication, imaging features provided by cardiac ultrasound, Cardiac magnetic resonance,&#xD;
           Angio CT and imaging post-processing data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>Rate of post-infarction heart failure</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome measure will be represented by the rate of post-infarction heart failure development, defined as the rate of re-admission in the hospital for heart failure or by a significant decrease in the ejection fraction (&lt;45%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of re-hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>Re-hospitalization for cardiovascular related causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of repeated revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Repeated myocardial revascularization procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major adverse cardiovascular events</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of major adverse cardiovascular events described as cardiovascular death, stroke.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>G1</arm_group_label>
    <description>Study subjects with STEMI and increased inflammatory response at 7 days after STEMI&#xD;
Interventions:&#xD;
Blood sampling&#xD;
transthoracic echocardiography&#xD;
Late Gadolinium-Enhancement Cardiac Magnetic Resonance&#xD;
Coronary Angio Computed Tomography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G2</arm_group_label>
    <description>Study subjects with STEMI and no increased inflammatory response at 7 days after STEMI&#xD;
Interventions:&#xD;
Blood sampling&#xD;
transthoracic echocardiography&#xD;
Late Gadolinium-Enhancement Cardiac Magnetic Resonance&#xD;
Coronary Angio Computed Tomography</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Assessment of complete blood count, biochemistry, inflammatory biomarkers, adhesion molecules</description>
    <arm_group_label>G1</arm_group_label>
    <arm_group_label>G2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>transthoracic echocardiography</intervention_name>
    <description>Assessment of the ventricular anatomy, size, function, speckle tracking, myocardial strain, valvular function.</description>
    <arm_group_label>G1</arm_group_label>
    <arm_group_label>G2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Late Gadolinium-Enhancement Cardiac Magnetic Resonance</intervention_name>
    <description>Assessment of the ventricular anatomy, function, viability, degree of fibrosis, quantification of infarct size, mass.</description>
    <arm_group_label>G1</arm_group_label>
    <arm_group_label>G2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Coronary Angio Computed Tomography</intervention_name>
    <description>Assessment of coronary plaque anatomy, morphology, vulnerability features, quantification of epicardial adipose tissue</description>
    <arm_group_label>G1</arm_group_label>
    <arm_group_label>G2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes patients from a single center with STEMI meeting inclusion and&#xD;
        exclusion criteria and undergoing primary PCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ST-segment elevation acute myocardial infarction treated by primary PCI&#xD;
             within the first 12 hours after the onset of symptoms&#xD;
&#xD;
          -  Ability to provide informed consent;&#xD;
&#xD;
          -  Patients aged at least 18 years;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with acute coronary syndrome in the last 30 days&#xD;
&#xD;
          -  Unwillingness or incapacity to provide informed consent;&#xD;
&#xD;
          -  Allergy to contrast media;&#xD;
&#xD;
          -  Absolute or relative contraindications to magnetic resonance imaging&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Women with childbearing potential in absence of any contraceptive treatment&#xD;
&#xD;
          -  Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring&#xD;
             dialysis;&#xD;
&#xD;
          -  Active malignancy or malignancy within the last 5 year prior to enrollment;&#xD;
&#xD;
          -  Conditions associated with an estimated life expectancy of under 1 year;&#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>Mirabela Morariu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Medicine, Pharmacy, Science and Technology of Tîrgu Mures, Romania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardio Med Medical Center</name>
      <address>
        <city>Targu Mures</city>
        <state>Mures</state>
        <zip>540102</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 30, 2022</last_update_submitted>
  <last_update_submitted_qc>July 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ST elevation myocardial infarction</keyword>
  <keyword>Inflammatory Response</keyword>
  <keyword>Coronary plaque vulnerability</keyword>
  <keyword>myocardial viability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ventricular Remodeling</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication will be available for interested parties.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The IPD sharing frame is starting 6 months after publication.</ipd_time_frame>
  </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/NCT03830944
org study id: CM0119-VIA
nct id: NCT03830944
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
VIABILITY study aims to investigate the link between systemic inflammation, pancoronary
      plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree),
      myocardial viability and ventricular remodeling in patients who had suffered a recent
      ST-segment elevation acute myocardial infarction (STEMI). The level of systemic inflammation
      in the acute phase of the myocardial infarction and at 1 month will be assessed on the basis
      of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteinases, interleukin-6).
      Pancoronary plaque vulnerability will be assessed: (1) in the acute phase of the infarction,
      based on serum biomarkers known to be associated with increased plaque vulnerability, such as
      adhesion molecules (V-CAM or I-CAM) determined from the blood samples collected in the first
      day after STEMI; (2) at 1 month after infarction, based on computed tomographic angiography
      analysis of vulnerability features present in all coronary plaques. Myocardial viability and
      remodeling will be assessed based on: (1) 3D speckle tracking echocardiography associated
      with dobutamine infusion; (2) MRI imaging associated with complex post-processing techniques
      for mapping myocardial fibrosis and scar at the level of left atrium and left ventricle. At
      the same time, CT imaging features associated with systemic and local inflammation, such as
      global epicardial fat or local pericoronary epicardial fat will be quantified in order to
      investigate the impact of inflammatory-mediated plaque vulnerability on the extent of
      myocardial damage in acute myocardial infarction. All these parameters will be investigated
      in patients with successful primary revascularization performed in a timely manner for
      ST-segment elevation acute myocardial infarction, who will be divided into 2 groups: group 1
      - patients who present persistence of an augmented inflammatory status defined as serum
      levels of hsCRP>3.0 mg/dl at discharge from the hospital or at 7 days postinfarction
      (whichever comes first), and group 2 - patients with no persistence of augmented inflammatory
      status (hsCRP<3.0 mg/dl).

      The primary endpoint of the study will be represented by the rate of post-infarction heart
      failure development, defined as the rate of re-admission in the hospital for heart failure or
      by a significant decrease in the ejection fraction (<45%).

      The secondary endpoints of the study will be:

        -  rate of re-hospitalization

        -  rate of repeated revascularization

        -  rate of major adverse cardiovascular events (MACE rate, including cardiovascular death
           or stroke)
Patients with acute myocardial infarction (AMI) who survive the acute event, very often
      present a significant deterioration of their clinical status with progression towards heart
      failure, which is directly linked to the extent of myocardial injury and the remodeling
      process starting immediately after infarction. The major aim of the urgent revascularization
      in STEMI is to save myocardial tissue from death and necrosis, in order to recover viable
      myocardium. It is well-known that one of the major factors that trigger an AMI is the
      systemic inflammation, which has a direct influence on coronary plaque vulnerability. At the
      same time, 20% of patients surviving an AMI present a recurrent cardiovascular event in the
      following 12 months, as a result of increased systemic inflammation triggered by the
      infarction, which leads to vulnerabilization of other atheromatous plaques from all the
      circulatory system in the post-infarction period. While the role of inflammation in acute
      coronary events is well established, the impact of inflammatory-mediated vulnerability of
      coronary plaques from the entire coronary tree on the extension of ventricular remodeling and
      scaring has not been elucidated so far.

      This is a clinical prospective, descriptive, single-center study which will be carried out in
      the University of Medicine, Pharmacy, Science and Technology Tîrgu Mures, Romania, in
      collaboration with two clinical sites: Center of Advanced Research in Multimodal Cardiac
      Imaging Cardio Med Tîrgu Mures, Romania and County Clinical Emergency Hospital Tîrgu Mures,
      Romania. The duration of the study is 2 years which includes the initial screening and the
      follow-up period.

      The study will enroll 100 subjects with STEMI who underwent successful revascularization of
      the culprit lesion in the first 12 hours after the onset of symptoms. Imaging biomarkers and
      laboratory analyses such as: high sensitive C Reactive Protein (hsCRP), matrix
      metalloproteinases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide
      (NT pro-BNP) will be determined in the first 24 hours after the index hospitalization. At 1
      month postinfarction all patients will undergo Dobutamine stress test associated with speckle
      tracking echocardiography for evaluation of myocardial function and viability, CMR for
      assessment of myocardial scar, function and remodeling, and Multislice Angio CT for
      assessment of pancoronary vulnerability, by complex characterization of vulnerability
      features in all the coronary plaques present in the coronary tree. All these parameters will
      be investigated in patients with successful primary percutaneous coronary revascularization,
      who will be divided into 2 groups: group 1 -patients with persistent elevation of systemic
      inflammatory biomarkers at discharge from the hospital or at day 7 (whichever comes first)
      (inflammation+ group); and group 2 - patients with no persistent elevation of systemic
      inflammatory biomarkers at discharge from the hospital or at day 7 (whichever comes first)
      (inflammation- group). In all patients, the following biomarkers will be determined: serum
      levels of inflammatory biomarkers, adhesion molecules and NT-proBNP at 24 hours and 7 days
      post procedure, the amount of myocardial fibrosis and scar in the left ventricle at 1 month,
      the degree of ventricular remodeling and myocardial perfusion at 1 month and the amount of
      epicardial fat surrounding the heart and the plaques. The study will be conducted over a
      period of 2 years, in which patients will be examined at baseline, and will be followed-up
      for MACE incidence.

      All patients will sign an informed written consent and will be checked for the exclusion
      criteria prior to enrollment.

      Study objectives:

      Primary: To investigate the link between coronary inflammation-mediated plaque vulnerability,
      myocardial viability and ventricular remodeling in the post-infarction period.

      Secondary:

        -  To investigate the impact of systemic inflammation on structural remodeling of the left
           ventricle in the post-infarction period

        -  To investigate the impact of local inflammatory response on pancoronary plaque
           vulnerability following an acute myocardial infarction.

      Study Timeline:

        -  Baseline - visit 1 (day 0)

        -  Obtain and document consent from participant on study consent form.

        -  Verify inclusion/exclusion criteria.

        -  Obtain demographic information, medical history, medication history, alcohol and tobacco
           use history.

        -  Record results of physical examinations and 12-lead ECG.

        -  Collect blood specimens (complete blood count, biochemistry, inflammatory biomarkers,
           acute adhesion molecules).

        -  Imaging procedures: transthoracic 2-D echocardiography/speckle tracking

        -  Visit 2 (day 7 / discharge from the hospital)

        -  -hsCRP

        -  Visit 3 (month 1)

        -  Coronary Computed Tomographic Angiography (vulnerability features, epicardial fat,
           myocardial perfusion)

        -  Cardiac Magnetic Resonance (myocardial fibrosis/scar, remodeling, viability)

        -  Dobutamine stress echocardiography / speckle tracking (viability)

        -  Visit 4,5,6 (month 3,6,9)

        -  Record results of physical examinations, 12-lead ECG and medical history.

        -  Imaging procedures: transthoracic 2-D echocardiography

        -  Final study visit (month 12)

        -  Record results of physical examinations, medical history,12-lead ECG

        -  Imaging procedures: transthoracic 2-D echocardiography

        -  End-point evaluation.

      Study procedures:

        -  Medical history, clinical examination, laboratory tests (complete blood count,
           biochemistry, serum level of hs-CRP, MMP, IL6, NT-pro-BNP, adhesion molecules);

        -  12-lead ECG

        -  2D transthoracic echocardiography with measurement of: cardiac diameters, volumes, left
           ventricular systolic and diastolic function, speckle tracking echo, dobutamine viability
           test.

        -  Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of
           myocardial scar and fibrosis, ventricular function and remodeling index.

        -  Angio Computed Tomography with assessment of coronary plaque vulnerability (based on
           vulnerability features: positive remodeling, spotty calcification, napkin-ring sign, low
           density plaque) and myocardial perfusion Data collection: All the information will be
           collected in a database that consists of patient's background, medical history,
           medication, imaging features provided by cardiac ultrasound, Cardiac magnetic resonance,
           Angio CT and imaging post-processing data.
observational model: Cohort
time perspective: Prospective
measure: Rate of post-infarction heart failure
time frame: 12 months
description: The primary outcome measure will be represented by the rate of post-infarction heart failure development, defined as the rate of re-admission in the hospital for heart failure or by a significant decrease in the ejection fraction (<45%).
measure: Rate of re-hospitalization
time frame: 12 months
description: Re-hospitalization for cardiovascular related causes
measure: Rate of repeated revascularization
time frame: 12 months
description: Repeated myocardial revascularization procedures
measure: Rate of major adverse cardiovascular events
time frame: 12 months
description: Occurrence of major adverse cardiovascular events described as cardiovascular death, stroke.
arm group label: G1
description: Study subjects with STEMI and increased inflammatory response at 7 days after STEMI
Interventions:
Blood sampling
transthoracic echocardiography
Late Gadolinium-Enhancement Cardiac Magnetic Resonance
Coronary Angio Computed Tomography
arm group label: G2
description: Study subjects with STEMI and no increased inflammatory response at 7 days after STEMI
Interventions:
Blood sampling
transthoracic echocardiography
Late Gadolinium-Enhancement Cardiac Magnetic Resonance
Coronary Angio Computed Tomography
intervention type: Diagnostic Test
intervention name: Blood sampling
description: Assessment of complete blood count, biochemistry, inflammatory biomarkers, adhesion molecules
arm group label: G1
arm group label: G2
intervention type: Diagnostic Test
intervention name: transthoracic echocardiography
description: Assessment of the ventricular anatomy, size, function, speckle tracking, myocardial strain, valvular function.
arm group label: G1
arm group label: G2
intervention type: Diagnostic Test
intervention name: Late Gadolinium-Enhancement Cardiac Magnetic Resonance
description: Assessment of the ventricular anatomy, function, viability, degree of fibrosis, quantification of infarct size, mass.
arm group label: G1
arm group label: G2
intervention type: Diagnostic Test
intervention name: Coronary Angio Computed Tomography
description: Assessment of coronary plaque anatomy, morphology, vulnerability features, quantification of epicardial adipose tissue
arm group label: G1
arm group label: G2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mirabela Morariu, MD
role: Principal Investigator
affiliation: University of Medicine, Pharmacy, Science and Technology of Tîrgu Mures, Romania
facility: 
country: Romania
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Inflammation
mesh term: Infarction
mesh term: Ventricular Remodeling
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication will be available for interested parties.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The IPD sharing frame is starting 6 months after publication.