<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/NCT04460482</url>
  </required_header>
  <id_info>
    <org_study_id>s-20200010</org_study_id>
    <nct_id>NCT04460482</nct_id>
  </id_info>
  <brief_title>Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction</brief_title>
  <official_title>Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</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 aim of this study is to investigate whether near-infrared guided percutaneous coronary&#xD;
      intervention in patients with acute myocardial infarction provides improved stent strut&#xD;
      coverage at six months compared to conventionally angiography guided percutaneous coronary&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Myocardial infarction (MI) secondary to atherosclerotic coronary artery disease is&#xD;
      mainly due to plaque-rupture with formation of a luminal thrombogenic material. Lesions&#xD;
      responsible for MI are more frequently composed of lipid-rich plaques (LRP) in both culprit&#xD;
      and in non-culprit lesions compared to lesions in patients with stable angina.&#xD;
&#xD;
      LRP is thought to be main precursor for future coronary events and may also have an impact on&#xD;
      complications following percutaneous coronary intervention (PCI). It has been previously&#xD;
      indicated that stent thrombosis (ST) and restenosis often occur when stenting a lipid-rich&#xD;
      plaque. And if using angiography guidance only during PCI, there is a potential risk of&#xD;
      implantation of a stent edge on a lipid pool, which can result in incomplete stent coverage&#xD;
      of a lesion. The incidence of restenosis and ST may be related to the lesion characteristics,&#xD;
      clinical presentation, antithrombotic treatment and stent design. Other factors may include&#xD;
      inflammatory reaction to the polymer coating containing drug that delays vascular healing,&#xD;
      insufficient stent strut coverage and incomplete stent apposition (ISA).&#xD;
&#xD;
      Invasive imaging modality can contribute to better understanding of the changes that occur in&#xD;
      the vessel wall during stent implantation.&#xD;
&#xD;
      Intravascular ultrasound (IVUS) combined with a new imaging modality called near-infrared&#xD;
      spectroscopy (NIRS) can identify LRP and provide a semi-quantitative estimate of amount of&#xD;
      LRP present within selected region of interest. The method is excellent to identify ISA and&#xD;
      improve stent implantation technique.&#xD;
&#xD;
      Optical coherence tomography (OCT) is a high resolution imaging modality that can analyze&#xD;
      healing pattern after stent implantation such as stent strut coverage.&#xD;
&#xD;
      Method The study is designed as a prospective randomized trial conducted at a single center&#xD;
      (Odense University Hospital). Patients with MI will be enrolled if they fulfill the criteria.&#xD;
      The study is submitted and approved by The Regional Committees on Health Research Ethics for&#xD;
      Southern Denmark (Project-ID: S-20200010) and Danish Data Agency (Journal nr.: 20/18008).&#xD;
&#xD;
      Eligible patients will be randomly assigned to either NIRS-guided PCI or conventual&#xD;
      angiography-guided PCI with implantation of Everolimus-eluting Xience stent, which is CE&#xD;
      marked. NIRS will be performed in both groups after predilation and stent implantation. In&#xD;
      NIRS-guided group the analyses will be used to identify LRP, and to measure vessel wall&#xD;
      diameter in reference segments and lesion length. In angiography-guided group the analyses&#xD;
      will not be available for the PCI operator and are for observation purpose only. OCT will be&#xD;
      performed in both groups after stent implantation, but will be only available for&#xD;
      interpretation in NIRS-guided group. In case of reintervention in NIRS-guided group, a final&#xD;
      OCT will be performed.&#xD;
&#xD;
      Patients will be contacted by telephone to evaluate the clinical situation and to reduce the&#xD;
      potential risk of dropout. After 6 months OCT will be performed in both groups to evaluate&#xD;
      stent strut coverage and vessel healing.&#xD;
&#xD;
      Statistics Assuming data are normally distributed, categorical data will be presented as&#xD;
      numbers and frequencies and compared using chi2-test. Continuous data will be presented as&#xD;
      mean ± SD and compared using Student t test. SPSS version 26.0 will be used for the&#xD;
      statistical analysis.&#xD;
&#xD;
      Sample size calculation An a priori power calculation at patient level with a mean expected&#xD;
      proportion of 75% and 95% covered stent struts at six months in the angio-guided and&#xD;
      NIRS-guided group, respectively, shows a sample size of 88 patients is required to reach&#xD;
      statistical significance. With 44 patients in each treatment group, and a 2-tailed&#xD;
      significance level of 0.05, the study has a power of 80%. With an expected drop-out rate of&#xD;
      15% due to non-compliance in relation to invasive procedures and subject to poor image&#xD;
      quality, 104 patients are required to be recruited in the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 2, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Eligible patients randomized to NIRS-guided or standard angiographic-guided intervention with DES</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Offline data analyzis are being performed without knowing which intervention group the patients are from</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of stent strut coverage</measure>
    <time_frame>6 months after index percutaneous coronary intervention</time_frame>
    <description>Proportion of stent strut coverage at 6 months follow up estimated by OCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uncovered stent struts</measure>
    <time_frame>6 months after index percutaneous coronary intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistent stent malapposition</measure>
    <time_frame>6 months after index percutaneous coronary intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal neointimal growth</measure>
    <time_frame>6 months after index percutaneous coronary intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Atherosclerosis</condition>
  <condition>Lipid-Rich Atherosclerosis of Coronary Artery</condition>
  <condition>Vascular Diseases</condition>
  <condition>Infarct Ischemia</condition>
  <arm_group>
    <arm_group_label>NIRS-guided PCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Near-infrared Spectroscopy guided Percutaneous coronary intervention with implantation of drug-eluting stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography-guided PCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Angiography-guided percutaneous coronary intervention with implantation of a drug-eluting stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Near-infrared spectroscopy (NIRS)</intervention_name>
    <description>NIRS-guided PCI</description>
    <arm_group_label>NIRS-guided PCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angiography</intervention_name>
    <description>Angiography guided PCI</description>
    <arm_group_label>Angiography-guided PCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute coronary syndrome (ST-elevation myocardial infarction and non-ST&#xD;
             elevation myocardial infarction) referred for invasive coronary angiography and&#xD;
             percutaneous coronary intervention at Department of Cardiology, Odense University&#xD;
             Hospital (Odense, Denmark)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in other randomized clinical trials&#xD;
&#xD;
          -  life expectancy &lt; 1 year&#xD;
&#xD;
          -  allergy to aspirin, clopidogrel, ticagrelor or prasugrel&#xD;
&#xD;
          -  eGFR &lt; 30 mL/min&#xD;
&#xD;
          -  tortuous and angiographically estimated extremely calcified lesions&#xD;
&#xD;
          -  ostial, left main and bifurcation lesions&#xD;
&#xD;
          -  lesions in a reference vessel diameter &lt; 2.0 mm&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  Scheduled for coronary artery bypass grafting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisette Okkels Jensen, MD PhD Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Manijeh Noori</investigator_full_name>
    <investigator_title>MD; PhD-student</investigator_title>
  </responsible_party>
  <keyword>drug-eluting stent</keyword>
  <keyword>near-infrared spectrocopy</keyword>
  <keyword>intravascular ultrasound</keyword>
  <keyword>optical coherence tomography</keyword>
  <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>Myocardial Infarction</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT04460482
org study id: s-20200010
nct id: NCT04460482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether near-infrared guided percutaneous coronary
      intervention in patients with acute myocardial infarction provides improved stent strut
      coverage at six months compared to conventionally angiography guided percutaneous coronary
      intervention.
Background Myocardial infarction (MI) secondary to atherosclerotic coronary artery disease is
      mainly due to plaque-rupture with formation of a luminal thrombogenic material. Lesions
      responsible for MI are more frequently composed of lipid-rich plaques (LRP) in both culprit
      and in non-culprit lesions compared to lesions in patients with stable angina.

      LRP is thought to be main precursor for future coronary events and may also have an impact on
      complications following percutaneous coronary intervention (PCI). It has been previously
      indicated that stent thrombosis (ST) and restenosis often occur when stenting a lipid-rich
      plaque. And if using angiography guidance only during PCI, there is a potential risk of
      implantation of a stent edge on a lipid pool, which can result in incomplete stent coverage
      of a lesion. The incidence of restenosis and ST may be related to the lesion characteristics,
      clinical presentation, antithrombotic treatment and stent design. Other factors may include
      inflammatory reaction to the polymer coating containing drug that delays vascular healing,
      insufficient stent strut coverage and incomplete stent apposition (ISA).

      Invasive imaging modality can contribute to better understanding of the changes that occur in
      the vessel wall during stent implantation.

      Intravascular ultrasound (IVUS) combined with a new imaging modality called near-infrared
      spectroscopy (NIRS) can identify LRP and provide a semi-quantitative estimate of amount of
      LRP present within selected region of interest. The method is excellent to identify ISA and
      improve stent implantation technique.

      Optical coherence tomography (OCT) is a high resolution imaging modality that can analyze
      healing pattern after stent implantation such as stent strut coverage.

      Method The study is designed as a prospective randomized trial conducted at a single center
      (Odense University Hospital). Patients with MI will be enrolled if they fulfill the criteria.
      The study is submitted and approved by The Regional Committees on Health Research Ethics for
      Southern Denmark (Project-ID: S-20200010) and Danish Data Agency (Journal nr.: 20/18008).

      Eligible patients will be randomly assigned to either NIRS-guided PCI or conventual
      angiography-guided PCI with implantation of Everolimus-eluting Xience stent, which is CE
      marked. NIRS will be performed in both groups after predilation and stent implantation. In
      NIRS-guided group the analyses will be used to identify LRP, and to measure vessel wall
      diameter in reference segments and lesion length. In angiography-guided group the analyses
      will not be available for the PCI operator and are for observation purpose only. OCT will be
      performed in both groups after stent implantation, but will be only available for
      interpretation in NIRS-guided group. In case of reintervention in NIRS-guided group, a final
      OCT will be performed.

      Patients will be contacted by telephone to evaluate the clinical situation and to reduce the
      potential risk of dropout. After 6 months OCT will be performed in both groups to evaluate
      stent strut coverage and vessel healing.

      Statistics Assuming data are normally distributed, categorical data will be presented as
      numbers and frequencies and compared using chi2-test. Continuous data will be presented as
      mean ± SD and compared using Student t test. SPSS version 26.0 will be used for the
      statistical analysis.

      Sample size calculation An a priori power calculation at patient level with a mean expected
      proportion of 75% and 95% covered stent struts at six months in the angio-guided and
      NIRS-guided group, respectively, shows a sample size of 88 patients is required to reach
      statistical significance. With 44 patients in each treatment group, and a 2-tailed
      significance level of 0.05, the study has a power of 80%. With an expected drop-out rate of
      15% due to non-compliance in relation to invasive procedures and subject to poor image
      quality, 104 patients are required to be recruited in the trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible patients randomized to NIRS-guided or standard angiographic-guided intervention with DES
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Offline data analyzis are being performed without knowing which intervention group the patients are from
measure: Proportion of stent strut coverage
time frame: 6 months after index percutaneous coronary intervention
description: Proportion of stent strut coverage at 6 months follow up estimated by OCT
measure: Uncovered stent struts
time frame: 6 months after index percutaneous coronary intervention
measure: Persistent stent malapposition
time frame: 6 months after index percutaneous coronary intervention
measure: Maximal neointimal growth
time frame: 6 months after index percutaneous coronary intervention
arm group label: NIRS-guided PCI
arm group type: Active Comparator
description: Near-infrared Spectroscopy guided Percutaneous coronary intervention with implantation of drug-eluting stent
arm group label: Angiography-guided PCI
arm group type: Active Comparator
description: Angiography-guided percutaneous coronary intervention with implantation of a drug-eluting stent
intervention type: Device
intervention name: Near-infrared spectroscopy (NIRS)
description: NIRS-guided PCI
arm group label: NIRS-guided PCI
intervention type: Device
intervention name: Angiography
description: Angiography guided PCI
arm group label: Angiography-guided PCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lisette Okkels Jensen, MD PhD Prof
role: Study Chair
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Manijeh Noori
investigator title: MD; PhD-student
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Myocardial Infarction
mesh term: Atherosclerosis
mesh term: Vascular Diseases
mesh term: Infarction
mesh term: Ischemia
sharing ipd: No