<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/NCT04431661</url>
  </required_header>
  <id_info>
    <org_study_id>The CAOCT Study</org_study_id>
    <nct_id>NCT04431661</nct_id>
  </id_info>
  <brief_title>CAOCT: Intra CoronAry Optical Computerized Tomography in out-of Hospital Cardiac Arrest Patients</brief_title>
  <official_title>CAOCT Study is a Prospective, Multi-centre, Single Cohort, Diagnostic Accuracy Study, Planned to Include 131 Patients in About 3 European Countries After Successful Return of Spontaneous Circulation After Out of Hospital Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ceric Sàrl</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ceric Sàrl</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>
      Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the&#xD;
      United States. Mortality is currently close to 40% among those patients who had been&#xD;
      successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless&#xD;
      ventricular tachycardia . Coronary artery disease is observed in up to 70% of patients with&#xD;
      OHCA and immediate coronary angiography . Current European and American guidelines recommend&#xD;
      immediate coronary angiography with primary angioplasty in OHCA patients with ST-segment&#xD;
      elevation on ECG after successful resuscitation . Furthermore, the identification of the&#xD;
      culprit lesion by coronary angiography among patients with an acute coronary syndrome (ACS)&#xD;
      and no OHCA is challenging. In a recent cardiac magnetic resonance study, Heitner et al.&#xD;
      found that in almost half of the patients with non-ST segment elevation ACS, the culprit&#xD;
      lesion was not properly detected or identified by coronary angiography. In the Coronary&#xD;
      Angiography after cardiac arrest (COACT) trial, a randomized controlled trial comparing&#xD;
      immediate versus delayed coronary angiography after OHCA in patients without ST segment&#xD;
      elevation on ECG, some degree of coronary artery disease was found in 64.5% of the patients&#xD;
      in the immediate angiography group and an unstable coronary lesion was identified in only&#xD;
      13.6% of the patients. However, in survivors of OHCA without ST segment elevation on ECG, the&#xD;
      use of intra coronary optical computerized tomography (OCT) led to identification of plaque&#xD;
      rupture (27%), plaque erosion (36%) and coronary thrombosis (59%) undetected on angiography.&#xD;
      There is hence a clear need to improve causality diagnosis among patients resuscitated after&#xD;
      OHCA and without ST segment elevation on ECG, and, in the case of coronary artery disease&#xD;
      detection, to better identify the culprit vessel/lesion ultimately leading to a targeted&#xD;
      treatment. These are the reasons why we have designed a prospective, multi-centre, single&#xD;
      cohort, diagnostic accuracy study: to better explore the incidence of a true ACS among OHCA&#xD;
      survivors and to evaluate the accuracy of angiography to detect the culprit lesion when&#xD;
      compared to OCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low patient recruitment rate and change of hopsital procedures for handling cardiac arrest&#xD;
    patients during emergency&#xD;
  </why_stopped>
  <start_date type="Actual">January 29, 2021</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of misclassification of at least one unstable coronary artery lesion per patient, between core lab angiography and core lab OCT assessments.</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>The core lab OCT analysis is considered as the gold standard for unstable coronary lesion detection.&#xD;
Detection of unstable coronary lesion by OCT includes atherosclerosis plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection.&#xD;
Angiographically, unstable coronary lesions are defined as coronary lesions with at least &gt;50% stenosis and the presence of characteristics of plaque disruption, including irregularity, dissection, haziness, or thrombus.&#xD;
A misclassification is either an unstable lesion detected by core lab OCT and misdiagnosed or undiagnosed on core lab angiography, or an unstable lesion as defined on core lab angiography but without plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection on core lab OCT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The misclassification rate per coronary artery segment analysis, on angiography versus OCT (both techniques peri procedural as assessed by investigators)</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>All analysable coronary segments according to the American Heart Association (AHA) classification (8) will be included in the final analysis. All paired (peri procedural as assessed by investigators angio and OCT) analysed segments will be included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients for whom peri procedural OCT findings change their management (including revascularization strategy) when compared to the initial therapeutic strategy decided upon after investigator-assessed on-line angiography</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>This endpoint represents a comparison between the management of the culprit lesion identified by the investigator after coronary angiography (and strictly captured in the electronic Case Report Form (eCRF) before OCT) and management of the culprit lesion as identified after OCT. Change in interventional management will include patients in whom an initially planned PCI was hold off after OCT and, vice versa, those declined a PCI in whom a PCI was finally decided after OCT. A patient for whom angiography and OCT-based diagnosis would lead to PCI of an additional but distinct coronary segment within the same vessel will be considered as a change in PCI plan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of unstable lesions (core lab OCT) intended to be left untreated by PCI after peri procedural (as assessed by investigators) angiography</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>The percentage of unstable lesions as defined by the core lab OCT core lab that were not defined as potential culprit lesion by the investigators after conventional angiography. This will reflect the incidence of undiagnosed and untreated coronary culprit coronary lesion after OHCA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of stable lesions (core lab OCT) intended to be treated by PCI after peri procedural (as assessed by investigators) conventional angiography</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>A stable lesion will be defined as a coronary stenosis ≥20% without any features of instability (no plaque rupture or erosion, no thrombosis) on core-lab OCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of misclassification for unstable lesion between peri procedural (as assessed by investigators) OCT and core lab OCT analysis.</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>The unstable lesion as detected during the procedure by the investigator and compared with the corelab analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of the procedure</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>Duration on the procedure will include timing from arterial sheath insertion to final run of angiography (angio), to final run of OCT (intracoronary imaging), and from the end of the angiography or intra coronary imaging to the end of the PCI procedure when applicable (Usually between set puncture to introducer removal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The irradiation during the procedure</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>Patient irradiation will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total procedural irradiation will also be calculated as the cumulative irradiation received during angio, intracoronary imaging and PCI if applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volume of contrast dye injection</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>The volume of contrast dye injection will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total volume of contrast dye injection will also be calculated as the cumulative volume injected during angio, intracoronary imaging and PCI when applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of OCT-related complications</measure>
    <time_frame>Intra operative, up to 12 months</time_frame>
    <description>The OCT related complications include coronary dissection, perforation, plaque embolization etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of Major Adverse Coronary and Cerebrovascular Events (MACCE).</measure>
    <time_frame>Day 1, Day 30 and Day 90</time_frame>
    <description>The MACCE evaluation will include all-cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of all-cause mortality</measure>
    <time_frame>Day 1, Day 30, Day 90 and Day 365</time_frame>
    <description>This includes all cause mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of stent thrombosis</measure>
    <time_frame>Day 1, Day 30 and Day 90</time_frame>
    <description>According to Academic Research Consortium-2 (ARC2) definition</description>
  </secondary_outcome>
  <enrollment type="Actual">28</enrollment>
  <condition>Out of Hospital Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Optical Coherence Tomography</intervention_name>
    <description>OCT (DragonFly, Abbott Vascular) will be performed after angiography. OCT images will be acquired using the 6F guide catheter compatible DragonFly System (Abbott Vascular, Santa Clara, USA). The catheter will be introduced into the first coronary artery via a standard 0.014-inch angioplasty wire, after prior injection of an intracoronary bolus of nitro-glycerine (according to the hemodynamic conditions of the patient). To remove all blood adequately from the imaging site, nonocclusive flushing will be performed using continuously inject via an automated power injector, and the OCT catheter will be pulled back at a speed of 18 mm/second to guarantee sufficient time to acquire images of a 54 mm long segment (frame density: 10 frames/mm).</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary Angiography</intervention_name>
    <description>The coronary angiography will be performed according to the strategies described in the consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups.Transradial or transfemoral 6F/7F approaches are recommended. The choice of diagnostic catheters, guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation is let to the investigator's discretion.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Per cutaneous coronary intervention</intervention_name>
    <description>Based on coronary angiography and OCT analyses by the investigators, PCI will be performed, preferentially for the identified culprit lesion(s) only. The guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation are left to physician discretion. The use of semi- or non-compliant balloons number and diameter of drug eluting stent(s) will also be left to the physician discretion, but post dilation will be strongly recommended in case of PCI. OCT can eventually be performed after stent implantation to guide, post dilation strategy.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All OHCA patients with no obvious non-cardiovascular reason managed by a pre-hospital&#xD;
        emergency system will be screened for inclusion in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of age ≥ 18 years and ≤ 85 years,&#xD;
&#xD;
          -  The delay between OHCA and basic life support (no flow period) is ≤ 5 minutes,&#xD;
&#xD;
          -  First recorded ECG exhibits a shockable rhythm (ventricular tachycardia/ventricular&#xD;
             fibrillation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is still receiving cardiac massage at the time of admission in the&#xD;
             cath-lab,&#xD;
&#xD;
          -  There is an obvious extra cardiac cause to the cardiac arrest (suicide, drowning,&#xD;
             hanging, trauma etc.),&#xD;
&#xD;
          -  The patient has prior coronary artery bypass grafting,&#xD;
&#xD;
          -  The patient has incessant ventricular tachycardia/fibrillation,&#xD;
&#xD;
          -  The patient has at least one acute or chronic coronary occlusion of an epicardial&#xD;
             coronary artery ≥2.0mm of diameter on conventional angiography, The coronary artery&#xD;
             anatomy does not allow realization of three vessels OCT according to the&#xD;
             interventional cardiologist (severe tortuosity, severe calcifications etc.),&#xD;
&#xD;
          -  The patient is in cardiogenic shock or with a left ventricular assistance device,&#xD;
&#xD;
          -  The post ROSC ECG (12 leads) exhibits ST segment elevation (defined as a ≥1mm ST&#xD;
             segment elevation in two or more contiguous standard leads or as a ≥2mm ST segment&#xD;
             elevation in two or more precordial leads),&#xD;
&#xD;
          -  The post ROSC ECG (12 leads) exhibits new left bundle block branch (LBBB).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Varenne, MD, PHD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Timone Adultes</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Serbia. School of medicine</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Serbia</country>
  </location_countries>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 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 Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</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/NCT04431661
org study id: The CAOCT Study
nct id: NCT04431661
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the
      United States. Mortality is currently close to 40% among those patients who had been
      successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless
      ventricular tachycardia . Coronary artery disease is observed in up to 70% of patients with
      OHCA and immediate coronary angiography . Current European and American guidelines recommend
      immediate coronary angiography with primary angioplasty in OHCA patients with ST-segment
      elevation on ECG after successful resuscitation . Furthermore, the identification of the
      culprit lesion by coronary angiography among patients with an acute coronary syndrome (ACS)
      and no OHCA is challenging. In a recent cardiac magnetic resonance study, Heitner et al.
      found that in almost half of the patients with non-ST segment elevation ACS, the culprit
      lesion was not properly detected or identified by coronary angiography. In the Coronary
      Angiography after cardiac arrest (COACT) trial, a randomized controlled trial comparing
      immediate versus delayed coronary angiography after OHCA in patients without ST segment
      elevation on ECG, some degree of coronary artery disease was found in 64.5% of the patients
      in the immediate angiography group and an unstable coronary lesion was identified in only
      13.6% of the patients. However, in survivors of OHCA without ST segment elevation on ECG, the
      use of intra coronary optical computerized tomography (OCT) led to identification of plaque
      rupture (27%), plaque erosion (36%) and coronary thrombosis (59%) undetected on angiography.
      There is hence a clear need to improve causality diagnosis among patients resuscitated after
      OHCA and without ST segment elevation on ECG, and, in the case of coronary artery disease
      detection, to better identify the culprit vessel/lesion ultimately leading to a targeted
      treatment. These are the reasons why we have designed a prospective, multi-centre, single
      cohort, diagnostic accuracy study: to better explore the incidence of a true ACS among OHCA
      survivors and to evaluate the accuracy of angiography to detect the culprit lesion when
      compared to OCT.
observational model: Other
time perspective: Prospective
measure: Rate of misclassification of at least one unstable coronary artery lesion per patient, between core lab angiography and core lab OCT assessments.
time frame: Intra operative, up to 12 months
description: The core lab OCT analysis is considered as the gold standard for unstable coronary lesion detection.
Detection of unstable coronary lesion by OCT includes atherosclerosis plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection.
Angiographically, unstable coronary lesions are defined as coronary lesions with at least >50% stenosis and the presence of characteristics of plaque disruption, including irregularity, dissection, haziness, or thrombus.
A misclassification is either an unstable lesion detected by core lab OCT and misdiagnosed or undiagnosed on core lab angiography, or an unstable lesion as defined on core lab angiography but without plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection on core lab OCT.
measure: The misclassification rate per coronary artery segment analysis, on angiography versus OCT (both techniques peri procedural as assessed by investigators)
time frame: Intra operative, up to 12 months
description: All analysable coronary segments according to the American Heart Association (AHA) classification (8) will be included in the final analysis. All paired (peri procedural as assessed by investigators angio and OCT) analysed segments will be included in the analysis.
measure: The percentage of patients for whom peri procedural OCT findings change their management (including revascularization strategy) when compared to the initial therapeutic strategy decided upon after investigator-assessed on-line angiography
time frame: Intra operative, up to 12 months
description: This endpoint represents a comparison between the management of the culprit lesion identified by the investigator after coronary angiography (and strictly captured in the electronic Case Report Form (eCRF) before OCT) and management of the culprit lesion as identified after OCT. Change in interventional management will include patients in whom an initially planned PCI was hold off after OCT and, vice versa, those declined a PCI in whom a PCI was finally decided after OCT. A patient for whom angiography and OCT-based diagnosis would lead to PCI of an additional but distinct coronary segment within the same vessel will be considered as a change in PCI plan.
measure: The percentage of unstable lesions (core lab OCT) intended to be left untreated by PCI after peri procedural (as assessed by investigators) angiography
time frame: Intra operative, up to 12 months
description: The percentage of unstable lesions as defined by the core lab OCT core lab that were not defined as potential culprit lesion by the investigators after conventional angiography. This will reflect the incidence of undiagnosed and untreated coronary culprit coronary lesion after OHCA.
measure: The percentage of stable lesions (core lab OCT) intended to be treated by PCI after peri procedural (as assessed by investigators) conventional angiography
time frame: Intra operative, up to 12 months
description: A stable lesion will be defined as a coronary stenosis ≥20% without any features of instability (no plaque rupture or erosion, no thrombosis) on core-lab OCT.
measure: The percentage of misclassification for unstable lesion between peri procedural (as assessed by investigators) OCT and core lab OCT analysis.
time frame: Intra operative, up to 12 months
description: The unstable lesion as detected during the procedure by the investigator and compared with the corelab analysis.
measure: The duration of the procedure
time frame: Intra operative, up to 12 months
description: Duration on the procedure will include timing from arterial sheath insertion to final run of angiography (angio), to final run of OCT (intracoronary imaging), and from the end of the angiography or intra coronary imaging to the end of the PCI procedure when applicable (Usually between set puncture to introducer removal).
measure: The irradiation during the procedure
time frame: Intra operative, up to 12 months
description: Patient irradiation will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total procedural irradiation will also be calculated as the cumulative irradiation received during angio, intracoronary imaging and PCI if applicable.
measure: The volume of contrast dye injection
time frame: Intra operative, up to 12 months
description: The volume of contrast dye injection will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total volume of contrast dye injection will also be calculated as the cumulative volume injected during angio, intracoronary imaging and PCI when applicable
measure: The rate of OCT-related complications
time frame: Intra operative, up to 12 months
description: The OCT related complications include coronary dissection, perforation, plaque embolization etc.
measure: The rate of Major Adverse Coronary and Cerebrovascular Events (MACCE).
time frame: Day 1, Day 30 and Day 90
description: The MACCE evaluation will include all-cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization.
measure: The rate of all-cause mortality
time frame: Day 1, Day 30, Day 90 and Day 365
description: This includes all cause mortality rate
measure: The rate of stent thrombosis
time frame: Day 1, Day 30 and Day 90
description: According to Academic Research Consortium-2 (ARC2) definition
intervention type: Procedure
intervention name: Optical Coherence Tomography
description: OCT (DragonFly, Abbott Vascular) will be performed after angiography. OCT images will be acquired using the 6F guide catheter compatible DragonFly System (Abbott Vascular, Santa Clara, USA). The catheter will be introduced into the first coronary artery via a standard 0.014-inch angioplasty wire, after prior injection of an intracoronary bolus of nitro-glycerine (according to the hemodynamic conditions of the patient). To remove all blood adequately from the imaging site, nonocclusive flushing will be performed using continuously inject via an automated power injector, and the OCT catheter will be pulled back at a speed of 18 mm/second to guarantee sufficient time to acquire images of a 54 mm long segment (frame density: 10 frames/mm).
intervention type: Procedure
intervention name: Coronary Angiography
description: The coronary angiography will be performed according to the strategies described in the consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups.Transradial or transfemoral 6F/7F approaches are recommended. The choice of diagnostic catheters, guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation is let to the investigator's discretion.
intervention type: Procedure
intervention name: Per cutaneous coronary intervention
description: Based on coronary angiography and OCT analyses by the investigators, PCI will be performed, preferentially for the identified culprit lesion(s) only. The guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation are left to physician discretion. The use of semi- or non-compliant balloons number and diameter of drug eluting stent(s) will also be left to the physician discretion, but post dilation will be strongly recommended in case of PCI. OCT can eventually be performed after stent implantation to guide, post dilation strategy.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Olivier Varenne, MD, PHD
role: Principal Investigator
facility: 
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country: Belgium
country: France
country: Serbia
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responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest