{"id":636,"date":"2021-08-17T00:41:17","date_gmt":"2021-08-16T22:41:17","guid":{"rendered":"https:\/\/semmelweis.hu\/research\/?page_id=636"},"modified":"2021-12-20T14:16:48","modified_gmt":"2021-12-20T13:16:48","slug":"heart-and-vascular-center","status":"publish","type":"page","link":"https:\/\/semmelweis.hu\/research\/services\/clinical-trials\/heart-and-vascular-center\/","title":{"rendered":"Heart and Vascular Center"},"content":{"rendered":"
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The Heart and Vascular Center of Semmelweis University re-established its Phase I Unit on the 18th<\/sup> September 2018. The Phase I Unit will carry on cardiovascular early-phase clinical studies according to the principles of Good Clinical Practice in healthy adults and special patient populations including, but not limited to first-in-human, dose-escalation, bioequivalence and medical device studies.<\/p>\n<\/div>\n<\/div>\n

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The Phase I Unit also involves cardiologist investigators with experience in clinical pharmacology, clinical study coordinators and nurses. A dedicated investigation bed in a single room with the backup of the intensive care unit of the Clinic has been assigned to the Phase I Unit monitored and alarmed 24 hours a day. The local pharmacy and laboratory fulfill all the possible needs of drug storage and sample processing.<\/p>\n

The leader and the principal investigator of the Phase I Unit is Professor B\u00e9la Merkely, the Rector of the Semmelweis University and the Chairman of the Heart and Vascular Center.<\/p>\n

SERVICES<\/strong><\/h4>\n
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  • Study management with seven full-employed clinical study coordinators<\/li>\n
  • Study conduct with more than hundred full-employed clinicians<\/li>\n
  • Recruitment of patients \/ volunteers through various networks<\/li>\n
  • Experience in conducting of clinical trials (2019 summary: n=70. Phase I: n=0; Phase II: n=6, Phase III: n=26, Phase IV: n=1, device: n=26, register: n=11)<\/li>\n<\/ul>\n

    FACILITIES<\/strong><\/h4>\n
      \n
    • Phase I unit equipped with 1 bed<\/li>\n
    • Intensive care unit with 12 beds (accreditation: 18\/09\/2018, conducted Phase I trials: none)<\/li>\n
    • Local pharmacy with full capacity<\/li>\n<\/ul>\n

      IN-HOUSE LABORATORY
      \n<\/strong><\/h4>\n
        \n
      • Laboratory procedures involving centrifuges, -20o<\/sup>C and -80o<\/sup>C freezers, central temperature control & alarm system<\/li>\n<\/ul>\n

        PRIMARY INVESTIGATORS<\/strong>
        \n<\/em><\/h4>\n
          \n
        • Professor B\u00e9la Merkely<\/li>\n
        • Professor L\u00e1szl\u00f3 Gell\u00e9r<\/li>\n
        • Associate professor D\u00e1vid Becker<\/li>\n
        • Associate professor Endre Zima<\/li>\n
        • Consultant cardiologist Gy\u00f6rgy B\u00e1rczi<\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

          The Heart and Vascular Center of Semmelweis University re-established its Phase I Unit on the 18th September 2018. The Phase I Unit will carry on cardiovascular early-phase clinical studies according to the principles of Good Clinical Practice in healthy adults and special patient populations including, but not limited to first-in-human, dose-escalation, bioequivalence and medical device …<\/p>\n","protected":false},"author":362,"featured_media":797,"parent":182,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[],"class_list":["post-636","page","type-page","status-publish","has-post-thumbnail","hentry","category-phase-1-trials"],"acf":[],"_links":{"self":[{"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/pages\/636","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/users\/362"}],"replies":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/comments?post=636"}],"version-history":[{"count":6,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/pages\/636\/revisions"}],"predecessor-version":[{"id":815,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/pages\/636\/revisions\/815"}],"up":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/pages\/182"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/media\/797"}],"wp:attachment":[{"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/media?parent=636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/categories?post=636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/semmelweis.hu\/research\/wp-json\/wp\/v2\/tags?post=636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}