[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03378739":3,"trial-entities:NCT03378739":89,"trial-summary:NCT03378739":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":24,"eligibility_criteria":43,"std_ages":49,"locations":52,"central_contacts":72,"overall_officials":77,"references":80,"see_also_links":88},"NCT03378739","U19-02-3438","Inova Cardiogenic Shock Registry (INOVA SHOCK)","Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry)","RECRUITING","2099-12-31","2026-03","2026-03-16","2018-01-01","Inova Health Care Services","OTHER",true,"To collect retrospective clinical outcomes related to acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus historical survival rates.\n\nTo collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017.\n\nTo collect outcomes related to implementation of mechanical circulatory support versus no circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO) versus intracorporeal axial-flow (Impella).\n\n• Assess survival at three time points.","Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute shall be included in this registry. This includes adults with and without decision making capacity over the age of 18 years old.\n\nThe primary investigator (PI) will designate the data points to be included in the database in order to assess the efficiency of procedures and protocols in the treatment of cardiogenic shock at the IHVI as administered by the Shock team, to identify relationships between treatment and negative morbidity and mortality outcomes, and to monitor and improve quality of care delivered.",[19],"Cardiogenic Shock",[21,22],"cardiogenic","shock","OBSERVATIONAL",null,[],{"count":27,"type":28},3000,"ESTIMATED",[30],{"type":31,"name":32,"description":33},"PROCEDURE","Cardiogenic Shock team activation","Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute by the designated Cardiogenic Shock Team.",[35],{"measure":36,"description":37,"timeFrame":38},"Retrospective review of Cardiogenic shock patients outcomes","To create an archive of retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock) and compare current versus historical survival rates.","1 Year",[],"ALL","18 Years","85 Years",{"inclusion":44,"exclusion":46,"raw_text":48},[45],"Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock.",[47],"Patients under the age of 18 will be excluded.","Inclusion Criteria:\n\n-Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock.\n\nExclusion Criteria:\n\n-Patients under the age of 18 will be excluded.",[50,51],"ADULT","OLDER_ADULT",[53],{"facility":54,"status":8,"city":55,"state":56,"zip":57,"country":58,"contacts":59,"geoPoint":69},"Inova Fairfax Hospital","Falls Church","Virginia","22042","United States",[60,63,66],{"name":61,"role":62},"Behnam Tehrani, MD","CONTACT",{"name":64,"role":65},"Alex Truesdell, MD","PRINCIPAL_INVESTIGATOR",{"name":67,"role":68},"Benham Tehrani, MD","SUB_INVESTIGATOR",{"lat":70,"lon":71},38.88233,-77.17109,[73],{"name":74,"role":62,"phone":75,"email":76},"Bhruga Shah","703-776-2828","bhruga.shah@inova.org",[78],{"name":79,"affiliation":13,"role":65},"Vanessa Blumer, MD",[81,85],{"pmid":82,"type":83,"citation":84},"35510546","DERIVED","Sinha SS, Rosner CM, Tehrani BN, Maini A, Truesdell AG, Lee SB, Bagchi P, Cameron J, Damluji AA, Desai M, Desai SS, Epps KC, deFilippi C, Flanagan MC, Genovese L, Moukhachen H, Park JJ, Psotka MA, Raja A, Shah P, Sherwood MW, Singh R, Tang D, Young KD, Welch T, O'Connor CM, Batchelor WB. Cardiogenic Shock From Heart Failure Versus Acute Myocardial Infarction: Clinical Characteristics, Hospital Course, and 1-Year Outcomes. Circ Heart Fail. 2022 Jun;15(6):e009279. doi: 10.1161\u002FCIRCHEARTFAILURE.121.009279. Epub 2022 May 5.",{"pmid":86,"type":83,"citation":87},"29954728","Tehrani B, Truesdell A, Singh R, Murphy C, Saulino P. Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study. JMIR Res Protoc. 2018 Jun 28;7(6):e160. doi: 10.2196\u002Fresprot.9761.",[],{"nct_id":4,"conditions":90,"biomarkers":93},[19,91,92],"Heart Failure","Myocardial Infarction",[],{"nct_id":4,"found":15,"summary":95,"prompt_version":104},{"design":96,"status":97,"heading":6,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study, meaning researchers are collecting information from existing patient records rather than giving new treatments. It plans to include up to 3000 participants.","completed","This study, called the Inova Cardiogenic Shock Registry, is looking back at information from patients who have experienced cardiogenic shock (a serious condition where your heart can't pump enough blood to meet your body's needs). It's focused on patients treated by the Cardiogenic Shock Team at the Inova Heart and Vascular Institute. The goal is to understand how well current treatments work, compare survival rates before and after the team was formed, and see how different types of mechanical support (like ECMO or Impella) affect outcomes. You could be included if you are between 18 and 85 years old and received care from the Cardiogenic Shock Team for acute decompensated heart failure cardiogenic shock or acute myocardial infarction cardiogenic shock. The study aims to gather information from up to 3000 patients. The current status of the study is unclear.","Patient outcomes will be reviewed for up to 1 year.",139,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]