xml: <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/NCT06040073</url>
    </required_header>
    <id_info>
      <org_study_id>2023-GSP-GG-3</org_study_id>
      <nct_id>NCT06040073</nct_id>
    </id_info>
    <brief_title>Natural History of Coronary Atherosclerosis</brief_title>
    <acronym>NASCENT</acronym>
    <official_title>Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</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>
        The present study sought to explore the predictive value of radial wall strain (RWS, derived&#xD;
        solely from angiograms) for coronary artery lesion progression compared with lesion&#xD;
        vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1&#xD;
        year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary&#xD;
        angiography (QCA) evaluation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The recently developed angiography-derived maximum RWS (RWSmax) was computed as the maximum&#xD;
        deformation of lumen diameter throughout the cardiac cycle, expressed as a percentage of the&#xD;
        largest lumen diameter. This approach offers a quantitative assessment of the biomechanical&#xD;
        attributes of coronary lesions. Consequently, it allows for the identification of lesion&#xD;
        vulnerability, potentially compensating for the limitations of intravascular imaging in&#xD;
        assessing lesion stability and optimizing strategies for identifying high-risk vulnerable&#xD;
        plaques in patients.&#xD;
  &#xD;
        In the present multicenter, prospective cohort of individuals with acute myocardial&#xD;
        infarction, we assessed the predictive significance of identifying vulnerable lesions using&#xD;
        an RWSmax threshold of ≥13%. The investigation aimed to determine the capacity of these&#xD;
        identified lesions to predict the progression of the disease at 1 year. Furthermore, the&#xD;
        study validated that predictive capacity of RWSmax was on par with, and not inferior to,&#xD;
        lesion vulnerability assessed by OCT in tracking lesion progression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Lesion progression assessed by QCA</measure>
      <time_frame>1 year</time_frame>
      <description>Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of major adverse cardiac events (MACE)</measure>
      <time_frame>1 year, 2 years, 3 years</time_frame>
      <description>Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of all-cause death</measure>
      <time_frame>1 year, 2 years, 3 years</time_frame>
      <description>Including cardiac or non-cardiac death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of new myocardial infarction</measure>
      <time_frame>1 year, 2 years, 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of unplanned revascularization</measure>
      <time_frame>1 year, 2 years, 3 years</time_frame>
      <description>Including infarction-related/non-infarction-related vessel revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of stent thrombosis</measure>
      <time_frame>1 year, 2 years, 3 years</time_frame>
      <description>Including probable and definite stent thrombosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>μQFR</measure>
      <time_frame>1 year</time_frame>
      <description>Angiography-derived FFR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RWSmax, %</measure>
      <time_frame>1 year</time_frame>
      <description>Angiography-derived radial wall strain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diameter stenosis by QCA, %</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by QCA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal fibrous cap thickness (FCTmin), mm</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by OCT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid arc, °</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by OCT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque burden, %</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by OCT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Index of plaque attenuation (IPA)</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by OCT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Virtual flow ratio (VFR)</measure>
      <time_frame>1 year</time_frame>
      <description>Measured by OCT</description>
    </secondary_outcome>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Coronary Artery Disease Progression</condition>
    <condition>Radial Wall Strain</condition>
    <condition>Atherosclerotic Lesion</condition>
    <condition>Optical Coherence Tomography</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult study participants with acute myocardial infarction complicated by multi-vessel&#xD;
          coronary artery diseases within 45 days.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  General Inclusion Criteria:&#xD;
  &#xD;
                 1. Age ≥18 years&#xD;
  &#xD;
                 2. Acute myocardial infarction ≤ 45 days&#xD;
  &#xD;
                 3. Planned coronary angiography examination or potential interventional treatment&#xD;
  &#xD;
            -  Angiographic Inclusion Criteria:&#xD;
  &#xD;
                 1. The presence of at least 1 non-flow-restricting lesion (visually estimated&#xD;
                    diameter stenosis: 30%-80%; QFR &gt; 0.80) in any non-infarct related artery with&#xD;
                    RVD ≥2.5 mm by visual assessment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  General exclusion Criteria:&#xD;
  &#xD;
                 1. Cardiogenic shock&#xD;
  &#xD;
                 2. Pregnant or woman of child-bearing potential&#xD;
  &#xD;
                 3. Life expectancy less than 1 year for non-cardiac causes&#xD;
  &#xD;
                 4. Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy&#xD;
  &#xD;
                 5. Prior CABG or planned CABG&#xD;
  &#xD;
            -  Angiographic exclusion Criteria:&#xD;
  &#xD;
                 1. Poor angiographic image quality precluding vessel contour detection or with&#xD;
                    suboptimal contrast opacification, branch ostium cannot be shown clearly, severe&#xD;
                    overlap in the stenosed segment or severe tortuosity of any interrogated vessel&#xD;
                    deemed not amenable to QFR or RWS measurement&#xD;
  &#xD;
                 2. An interrogated lesion require surgical bypass grafting&#xD;
  &#xD;
                 3. Unable to judge culprit lesion or infarct-related artery according to current&#xD;
                    evidence&#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>Lei Song, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fuwai Hospital, CAMS &amp; PUMC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lei Song, MD</last_name>
      <phone>01088322564</phone>
      <email>drsong@vip.163.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
      <investigator_full_name>Lei Song, MD</investigator_full_name>
      <investigator_title>Director of the Coronary Heart Disease Ward, First Section</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
      <mesh_term>Disease Progression</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040073
  org study id: 2023-GSP-GG-3
  nct id: NCT06040073
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study sought to explore the predictive value of radial wall strain (RWS, derived
        solely from angiograms) for coronary artery lesion progression compared with lesion
        vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1
        year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary
        angiography (QCA) evaluation.
  The recently developed angiography-derived maximum RWS (RWSmax) was computed as the maximum
        deformation of lumen diameter throughout the cardiac cycle, expressed as a percentage of the
        largest lumen diameter. This approach offers a quantitative assessment of the biomechanical
        attributes of coronary lesions. Consequently, it allows for the identification of lesion
        vulnerability, potentially compensating for the limitations of intravascular imaging in
        assessing lesion stability and optimizing strategies for identifying high-risk vulnerable
        plaques in patients.
  
        In the present multicenter, prospective cohort of individuals with acute myocardial
        infarction, we assessed the predictive significance of identifying vulnerable lesions using
        an RWSmax threshold of ≥13%. The investigation aimed to determine the capacity of these
        identified lesions to predict the progression of the disease at 1 year. Furthermore, the
        study validated that predictive capacity of RWSmax was on par with, and not inferior to,
        lesion vulnerability assessed by OCT in tracking lesion progression.
  observational model: Cohort
  time perspective: Prospective
  measure: Lesion progression assessed by QCA
  time frame: 1 year
  description: Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation
  measure: Incidence of major adverse cardiac events (MACE)
  time frame: 1 year, 2 years, 3 years
  description: Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization
  measure: Incidence of all-cause death
  time frame: 1 year, 2 years, 3 years
  description: Including cardiac or non-cardiac death
  measure: Incidence of new myocardial infarction
  time frame: 1 year, 2 years, 3 years
  measure: Incidence of unplanned revascularization
  time frame: 1 year, 2 years, 3 years
  description: Including infarction-related/non-infarction-related vessel revascularization
  measure: Incidence of stent thrombosis
  time frame: 1 year, 2 years, 3 years
  description: Including probable and definite stent thrombosis
  measure: μQFR
  time frame: 1 year
  description: Angiography-derived FFR
  measure: RWSmax, %
  time frame: 1 year
  description: Angiography-derived radial wall strain
  measure: Diameter stenosis by QCA, %
  time frame: 1 year
  description: Measured by QCA
  measure: Minimal fibrous cap thickness (FCTmin), mm
  time frame: 1 year
  description: Measured by OCT
  measure: Lipid arc, °
  time frame: 1 year
  description: Measured by OCT
  measure: Plaque burden, %
  time frame: 1 year
  description: Measured by OCT
  measure: Index of plaque attenuation (IPA)
  time frame: 1 year
  description: Measured by OCT
  measure: Virtual flow ratio (VFR)
  time frame: 1 year
  description: Measured by OCT
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lei Song, MD
  role: Principal Investigator
  affiliation: Fuwai Hospital, CAMS & PUMC
  last name: Lei Song, MD
  phone: 01088322564
  email: drsong@vip.163.com
  responsible party type: Principal Investigator
  investigator affiliation: China National Center for Cardiovascular Diseases
  investigator full name: Lei Song, MD
  investigator title: Director of the Coronary Heart Disease Ward, First Section
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Atherosclerosis
  mesh term: Disease Progression