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/NCT06013813</url>
    </required_header>
    <id_info>
      <org_study_id>23-1367</org_study_id>
      <nct_id>NCT06013813</nct_id>
    </id_info>
    <brief_title>Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI</brief_title>
    <official_title>Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Nacional de Cardiologia Ignacio Chavez</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Nacional de Cardiologia Ignacio Chavez</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This clinical trial aims to compare conventional radial access versus distal radial access in&#xD;
        patients with STEMI undergoing PCI. The main question it aims to answer is:&#xD;
  &#xD;
        • Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not&#xD;
        inferior when comparing the distal radial approach versus the conventional radial approach ?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  sign the informed consent to enroll in the clinical trial.&#xD;
  &#xD;
          -  will agree to be treated by PCI&#xD;
  &#xD;
          -  will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.&#xD;
  &#xD;
        If there is a comparison group:&#xD;
  &#xD;
        Researchers will compare conventional radial access vs distal radial access to see if the&#xD;
        distal approach is not inferior compared to the conventional radial access in order to offer&#xD;
        less or equal MACE and a similar rate of a successful procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3 (Bleeding Academic Research Consortium)</measure>
      <time_frame>30 days after PCI</time_frame>
      <description>death, myocardial infarction and cerebral vascular event at 30 days (yes / no), bleeding measure will be with BARC classification.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2922</enrollment>
    <condition>STEMI - ST Elevation Myocardial Infarction</condition>
    <condition>Myocardial Infarction</condition>
    <condition>Acute Coronary Syndrome</condition>
    <arm_group>
      <arm_group_label>conventional radial access</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>STEMI interventional treatment via conventional radial access</description>
    </arm_group>
    <arm_group>
      <arm_group_label>distal radial access</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>STEMI interventional treatment via distal radial access</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>percutaneous coronary intervention (PCI)</intervention_name>
      <description>Conventional vs distal radial access will be selected with computer randomization 1:1</description>
      <arm_group_label>conventional radial access</arm_group_label>
      <arm_group_label>distal radial access</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  STEMI patients underwent PCI.&#xD;
  &#xD;
            -  Patent radial access (distal and conventional)&#xD;
  &#xD;
            -  Patients who agree to participate in the study and sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiogenic shock.&#xD;
  &#xD;
            -  Previous coronary artery bypass grafting (CABG).&#xD;
  &#xD;
            -  Absence of palpable radial pulse.&#xD;
  &#xD;
            -  Arteriovenous fistula for hemodialysis.&#xD;
  &#xD;
            -  Previous radial artery occlusion.&#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>Guering Eid Lidt, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Guering Eid-Lidt</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Juan Carlos Plata Corona, PhD</last_name>
      <phone>+522212187940</phone>
      <email>juancarlosplatacorona3@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Guering Eid Lidt, PhD</last_name>
      <phone>+525585803787</phone>
      <email>gueringeid@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Instituto Nacional de Cardiología Ignacio Chávez</name>
        <address>
          <city>Mexico City</city>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlos Plata</last_name>
        <phone>+55 2212187940</phone>
        <email>juancarlosplatacorona3@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Norman Said Vega Servin, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arnoldo Enmanuel Loaisiga Saenz, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eduardo Agustin Arias Sánchez, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jorge Gaspar Hernandez, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <reference>
      <citation>Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035.</citation>
      <PMID>30354598</PMID>
    </reference>
    <reference>
      <citation>Mamas MA, Anderson SG, Carr M, Ratib K, Buchan I, Sirker A, Fraser DG, Hildick-Smith D, de Belder M, Ludman PF, Nolan J; British Cardiovascular Intervention Society; National Institute for Cardiovascular Outcomes Research. Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention. J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64. doi: 10.1016/j.jacc.2014.05.075.</citation>
      <PMID>25301457</PMID>
    </reference>
    <reference>
      <citation>Ferrante G, Rao SV, Juni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29.</citation>
      <PMID>27372195</PMID>
    </reference>
    <reference>
      <citation>Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.</citation>
      <PMID>25791214</PMID>
    </reference>
    <reference>
      <citation>Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.</citation>
      <PMID>21670242</PMID>
    </reference>
    <reference>
      <citation>Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.</citation>
      <PMID>21470671</PMID>
    </reference>
    <reference>
      <citation>Mehta SR, Jolly SS, Cairns J, Niemela K, Rao SV, Cheema AN, Steg PG, Cantor WJ, Dzavik V, Budaj A, Rokoss M, Valentin V, Gao P, Yusuf S; RIVAL Investigators. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490-9. doi: 10.1016/j.jacc.2012.07.050. Epub 2012 Oct 24.</citation>
      <PMID>23103036</PMID>
    </reference>
    <reference>
      <citation>Ferrante G, Condello F, Rao SV, Maurina M, Jolly S, Stefanini GG, Reimers B, Condorelli G, Lefevre T, Pancholy SB, Bertrand O, Valgimigli M. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2297-2311. doi: 10.1016/j.jcin.2022.09.006.</citation>
      <PMID>36423974</PMID>
    </reference>
    <reference>
      <citation>Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.</citation>
      <PMID>33602433</PMID>
    </reference>
    <reference>
      <citation>Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.</citation>
      <PMID>31753298</PMID>
    </reference>
    <reference>
      <citation>Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN, Salido DZ, Vega Servin NS, Soto-Lopez ME, Gaspar J. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022 May 23;15(10):1022-1029. doi: 10.1016/j.jcin.2022.03.011.</citation>
      <PMID>35589232</PMID>
    </reference>
    <reference>
      <citation>Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.</citation>
      <PMID>35595673</PMID>
    </reference>
    <results_reference>
      <citation>Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.</citation>
      <PMID>30165437</PMID>
    </results_reference>
    <results_reference>
      <citation>Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9. Erratum In: J Am Coll Cardiol. 2022 Apr 19;79(15):1547.</citation>
      <PMID>34895950</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Nacional de Cardiologia Ignacio Chavez</investigator_affiliation>
      <investigator_full_name>Guering Eid Lidt</investigator_full_name>
      <investigator_title>Director of Cardiac Catheterization Lab</investigator_title>
    </responsible_party>
    <keyword>STEMI</keyword>
    <keyword>distal radial access</keyword>
    <keyword>conventional radial access</keyword>
    <keyword>MACE</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Acute Coronary Syndrome</mesh_term>
      <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all collected IPD will be shared</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>january 2025 to january 2026</ipd_time_frame>
      <ipd_access_criteria>IPD will be shared for related studies, without distinctions in the nature of each study, information may be freely requested directly by e-mail and each request will be evaluated by the principal investigator of the study.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 22, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT06013813/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06013813
  org study id: 23-1367
  nct id: NCT06013813
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to compare conventional radial access versus distal radial access in
        patients with STEMI undergoing PCI. The main question it aims to answer is:
  
        • Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not
        inferior when comparing the distal radial approach versus the conventional radial approach ?
  
        Participants will:
  
          -  sign the informed consent to enroll in the clinical trial.
  
          -  will agree to be treated by PCI
  
          -  will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.
  
        If there is a comparison group:
  
        Researchers will compare conventional radial access vs distal radial access to see if the
        distal approach is not inferior compared to the conventional radial access in order to offer
        less or equal MACE and a similar rate of a successful procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3 (Bleeding Academic Research Consortium)
  time frame: 30 days after PCI
  description: death, myocardial infarction and cerebral vascular event at 30 days (yes / no), bleeding measure will be with BARC classification.
  arm group label: conventional radial access
  arm group type: Active Comparator
  description: STEMI interventional treatment via conventional radial access
  arm group label: distal radial access
  arm group type: Active Comparator
  description: STEMI interventional treatment via distal radial access
  intervention type: Procedure
  intervention name: percutaneous coronary intervention (PCI)
  description: Conventional vs distal radial access will be selected with computer randomization 1:1
  arm group label: conventional radial access
  arm group label: distal radial access
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guering Eid Lidt, PhD
  role: Study Chair
  affiliation: Guering Eid-Lidt
  last name: Juan Carlos Plata Corona, PhD
  phone: +522212187940
  email: juancarlosplatacorona3@gmail.com
  last name: Guering Eid Lidt, PhD
  phone: +525585803787
  email: gueringeid@gmail.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Mexico
  citation: Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035.
  PMID: 30354598
  citation: Mamas MA, Anderson SG, Carr M, Ratib K, Buchan I, Sirker A, Fraser DG, Hildick-Smith D, de Belder M, Ludman PF, Nolan J; British Cardiovascular Intervention Society; National Institute for Cardiovascular Outcomes Research. Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention. J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64. doi: 10.1016/j.jacc.2014.05.075.
  PMID: 25301457
  citation: Ferrante G, Rao SV, Juni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29.
  PMID: 27372195
  citation: Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.
  PMID: 25791214
  citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
  PMID: 21670242
  citation: Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.
  PMID: 21470671
  citation: Mehta SR, Jolly SS, Cairns J, Niemela K, Rao SV, Cheema AN, Steg PG, Cantor WJ, Dzavik V, Budaj A, Rokoss M, Valentin V, Gao P, Yusuf S; RIVAL Investigators. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490-9. doi: 10.1016/j.jacc.2012.07.050. Epub 2012 Oct 24.
  PMID: 23103036
  citation: Ferrante G, Condello F, Rao SV, Maurina M, Jolly S, Stefanini GG, Reimers B, Condorelli G, Lefevre T, Pancholy SB, Bertrand O, Valgimigli M. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2297-2311. doi: 10.1016/j.jcin.2022.09.006.
  PMID: 36423974
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  PMID: 34895950
  responsible party type: Principal Investigator
  investigator affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
  investigator full name: Guering Eid Lidt
  investigator title: Director of Cardiac Catheterization Lab
  mesh term: Myocardial Infarction
  mesh term: Acute Coronary Syndrome
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Syndrome
  mesh term: Infarction
  sharing ipd: Yes
  ipd description: all collected IPD will be shared
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: january 2025 to january 2026
  ipd access criteria: IPD will be shared for related studies, without distinctions in the nature of each study, information may be freely requested directly by e-mail and each request will be evaluated by the principal investigator of the study.
  provided document: 