<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/NCT04444037</url>
  </required_header>
  <id_info>
    <org_study_id>OCT in ACS patients</org_study_id>
    <nct_id>NCT04444037</nct_id>
  </id_info>
  <brief_title>Impact of OCT Imaging on Decision Making During PCI in ACS Patients</brief_title>
  <official_title>Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wakayama Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optical coherence tomography (OCT) provides valuable information to guide percutaneous&#xD;
      coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation,&#xD;
      stent sizing, and stent optimization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion&#xD;
      morphologies and larger extent of coronary atherosclerosis compared with stable coronary&#xD;
      artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and&#xD;
      which may improve acute results and late outcomes of PCI. Stent expansion immediately after&#xD;
      PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical&#xD;
      outcomes in many previous trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent difference in lumen expansion in stent treated lesion</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes at 1 year follow up</measure>
    <time_frame>During 1 year following the index procedure</time_frame>
    <description>Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">390</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>OCT-guided PCI</arm_group_label>
    <description>PCI procedure was done with intra-coronary imaging OCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography-guided PCI</arm_group_label>
    <description>PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT-guided PCI</intervention_name>
    <description>using optical coherence tomography imaging to help PCI procedure</description>
    <arm_group_label>OCT-guided PCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient either underwent PCI with angiography alone or OCT guided and is grouped&#xD;
        accordingly&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presented with acute coronary syndrome.&#xD;
&#xD;
          -  PCI was done to them with stent implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multivessel PCI at the index procedure.&#xD;
&#xD;
          -  Patients with ACS due to graft failure post CABG.&#xD;
&#xD;
          -  Patients treated with no stent implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yehia T Kishk, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hossam H Ali, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Abdel-Galeel, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Takashi Akasaka, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Wakayama Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wakayama Medical University</name>
      <address>
        <city>Wakayama</city>
        <zip>641-8509</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Wu S, Liu W, Guo Y, Zeng Y, Zhou Z, Zhao Y, Liu Y, Shi D, Wang Z, Ge H, Wang J, Jin P, Zhou Y. The impact of acute coronary syndrome on late drug-eluting stents restenosis: Insights from optical coherence tomography. Medicine (Baltimore). 2017 Dec;96(52):e9515. doi: 10.1097/MD.0000000000009515.</citation>
    <PMID>29384957</PMID>
  </reference>
  <reference>
    <citation>Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.</citation>
    <PMID>29121226</PMID>
  </reference>
  <reference>
    <citation>Khalifa AKM, Kubo T, Ino Y, Terada K, Emori H, Higashioka D, Katayama Y, Takahata M, Shimamura K, Shiono Y, Matsuo Y, Tanaka A, Hozumi T, Akasaka T. Optical Coherence Tomography Comparison of Percutaneous Coronary Intervention Among Plaque Rupture, Erosion, and Calcified Nodule in Acute Myocardial Infarction. Circ J. 2020 May 25;84(6):911-916. doi: 10.1253/circj.CJ-20-0014. Epub 2020 Apr 18.</citation>
    <PMID>32307358</PMID>
  </reference>
  <reference>
    <citation>Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Ino Y, Kitabata H, Shimokawa T, Akasaka T. Comparison between Optical COherence tomography guidance and Angiography guidance in percutaneous coronary intervention (COCOA): Study protocol for a randomized controlled trial. J Cardiol. 2018 Aug;72(2):170-175. doi: 10.1016/j.jjcc.2018.01.005. Epub 2018 Mar 2.</citation>
    <PMID>29486964</PMID>
  </reference>
  <reference>
    <citation>Otake H, Kubo T, Shinke T, Hibi K, Tanaka S, Ishida M, Kataoka T, Takaya T, Iwasaki M, Sonoda S, Ioji T, Akasaka T. OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial. J Cardiol. 2020 Sep;76(3):317-321. doi: 10.1016/j.jjcc.2020.03.010. Epub 2020 Apr 24.</citation>
    <PMID>32340781</PMID>
  </reference>
  <reference>
    <citation>TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.</citation>
    <PMID>4038784</PMID>
  </reference>
  <reference>
    <citation>Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.</citation>
    <PMID>27806900</PMID>
  </reference>
  <reference>
    <citation>Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.</citation>
    <PMID>27573032</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amir Khalifa Mahfouz Khalifa</investigator_full_name>
    <investigator_title>Principle investigator, Cardiology department</investigator_title>
  </responsible_party>
  <keyword>OCT, stent implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Nothing</ipd_description>
  </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/NCT04444037
org study id: OCT in ACS patients
nct id: NCT04444037
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Optical coherence tomography (OCT) provides valuable information to guide percutaneous
      coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation,
      stent sizing, and stent optimization.
OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion
      morphologies and larger extent of coronary atherosclerosis compared with stable coronary
      artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and
      which may improve acute results and late outcomes of PCI. Stent expansion immediately after
      PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical
      outcomes in many previous trials.
observational model: Case-Control
time perspective: Retrospective
measure: Percent difference in lumen expansion in stent treated lesion
time frame: Immediately after the procedure
description: Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.
measure: Clinical outcomes at 1 year follow up
time frame: During 1 year following the index procedure
description: Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke
arm group label: OCT-guided PCI
description: PCI procedure was done with intra-coronary imaging OCT.
arm group label: Angiography-guided PCI
description: PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone
intervention type: Device
intervention name: OCT-guided PCI
description: using optical coherence tomography imaging to help PCI procedure
arm group label: OCT-guided PCI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Yehia T Kishk, MD
role: Study Chair
affiliation: Assiut University
last name: Hossam H Ali, MD
role: Study Chair
affiliation: Assiut University
last name: Ahmed Abdel-Galeel, MD
role: Study Chair
affiliation: Assiut University
last name: Takashi Akasaka, MD, PhD
role: Study Chair
affiliation: Wakayama Medical University
facility: 
country: Japan
citation: Wu S, Liu W, Guo Y, Zeng Y, Zhou Z, Zhao Y, Liu Y, Shi D, Wang Z, Ge H, Wang J, Jin P, Zhou Y. The impact of acute coronary syndrome on late drug-eluting stents restenosis: Insights from optical coherence tomography. Medicine (Baltimore). 2017 Dec;96(52):e9515. doi: 10.1097/MD.0000000000009515.
PMID: 29384957
citation: Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.
PMID: 29121226
citation: Khalifa AKM, Kubo T, Ino Y, Terada K, Emori H, Higashioka D, Katayama Y, Takahata M, Shimamura K, Shiono Y, Matsuo Y, Tanaka A, Hozumi T, Akasaka T. Optical Coherence Tomography Comparison of Percutaneous Coronary Intervention Among Plaque Rupture, Erosion, and Calcified Nodule in Acute Myocardial Infarction. Circ J. 2020 May 25;84(6):911-916. doi: 10.1253/circj.CJ-20-0014. Epub 2020 Apr 18.
PMID: 32307358
citation: Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Ino Y, Kitabata H, Shimokawa T, Akasaka T. Comparison between Optical COherence tomography guidance and Angiography guidance in percutaneous coronary intervention (COCOA): Study protocol for a randomized controlled trial. J Cardiol. 2018 Aug;72(2):170-175. doi: 10.1016/j.jjcc.2018.01.005. Epub 2018 Mar 2.
PMID: 29486964
citation: Otake H, Kubo T, Shinke T, Hibi K, Tanaka S, Ishida M, Kataoka T, Takaya T, Iwasaki M, Sonoda S, Ioji T, Akasaka T. OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial. J Cardiol. 2020 Sep;76(3):317-321. doi: 10.1016/j.jjcc.2020.03.010. Epub 2020 Apr 24.
PMID: 32340781
citation: TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.
PMID: 4038784
citation: Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.
PMID: 27806900
citation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.
PMID: 27573032
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amir Khalifa Mahfouz Khalifa
investigator title: Principle investigator, Cardiology department
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: Nothing