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Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock (VANQUISH SHOCK)

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ClinicalTrials.gov Identifier: NCT05185492
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
STAVROS G DRAKOS, University of Utah

Brief Summary:
This large real-world international prospective registry will provide a unique opportunity to comprehensively understand the contemporary management, clinical course and short as well as long-term outcomes of all Cardiogenic Shock (CS) patients cared for at four high volume dedicated shock care centers. As the first true North American multicenter CS collaborative with a uniform dedicated and comprehensive case report form, the high patient volumes and wide spectrum of clinical acuity seen at these institutions will provide valuable insight into the factors associated with adverse outcomes; and will serve as a blueprint for future clinical trial designs that may better inform clinical practice.

Condition or disease
Cardiogenic Shock Acute Myocardial Infarction

Detailed Description:

Cardiogenic shock (CS) is a hemodynamically complex and morbid syndrome characterized by frank circulatory collapse and end organ malperfusion stemming from severely impaired myocardial contractility. Despite advances in early reperfusion and regionalized systems of care, it remains the leading cause of in-hospital death following acute myocardial infarction (AMI) to this day, with mortality rates in excess of 40%. CS is also multifactorial with etiologies that extend beyond the reaches of acute coronary thrombosis, as more than 60% of cases may be due to acute decompensated heart failure (ADHF), a heterogenous conglomeration of disease states that remain poorly understood with equally dismal outcomes. In addition, while there has been a growing interest and significant uptake in the utilization of percutaneous mechanical circulatory support devices (pMCS) capable of providing greater procedural hemodynamics compared to the traditional intra-aortic balloon pump (IABP), they have yet to demonstrate a survival benefit.

In the absence of randomized trials to inform clinical care, there has been a growing interest in the development of an algorithmic approach to guide CS management, predicated on: 1) Early disease recognition; 2) Classification using a standardized nomenclature that incorporates comprehensive hemodynamics; 3) Selective and phenotypically tailored selective circulatory support; and 4) Multidisciplinary team-based care. While preliminary short-term results from United States CS registries employing such an approach has been favorable, there remain gaps in knowledge regarding a number of clinical domains in CS care, including: 1) Prognostic validation of invasive hemodynamics and risk stratification tools at the time of diagnosis; 2) Best practices for revascularization using contemporary therapies for AMI-CS patients; 3) Clinical predictors of outcomes among the different severity stages of CS; 4) Potential merits of varying care models (hub-and-spoke networks, high intensity cardiac intensive care units; 5) Ideal weaning strategies for peripheral mechanical circulatory support (pMCS) devices; and 6) Intermediate and long-term outcomes following the index clinical event, including health-related quality of life measures in this highly frail and vulnerable patient population.

This registry will prospectively and retrospectively follow all patients admitted to their respective health care systems with the primary diagnosis of CS. Unlike other registries, patients will be followed even if mechanical circulatory support is not implemented. Each patient will be followed from time of hospital admission to disposition, and at 30 days, 6 months and 1 year following discharge. A comprehensive and detailed evaluation of each patient and de-identified variables will be collected during these time periods, including baseline demographics, index and serial hemodynamic/metabolic assessments, and clinical care during the longitudinal hospital course. Data will be collected regarding revascularization strategies, vasopressor dosing and pMCS device utilization, to include weaning and escalation strategies. Information will also be collected regarding any morbidities sustained during the course of care, both in the cardiac intensive care unit (CICU) and during the post-ICU course. These include major bleeding, vascular complications requiring surgical or endovascular therapy, device-related hemolysis, need for renal replacement therapy and stroke. Among patients surviving the index hospitalization, they will also undergo cognitive and health-related quality of life evaluations using validated instruments at 30 days, 6 months and 1 year.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
Cardiogenic shock cohort
Primary diagnosis of Cardiogenic Shock at the time of index evaluation. The clinical and hemodynamic criteria used to diagnose Cardiogenic Shock will be those as defined in the Society for Cardiovascular Angiography and Interventions clinical expert consensus statement on the classification of cardiogenic shock.



Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    Percentage of participants alive at analysis time points


Secondary Outcome Measures :
  1. Vascular Complications [ Time Frame: 1 year ]
    Percentage of participants experiencing stroke or need for renal replacement therapy

  2. Major Adverse Cardiovascular and Cerebrovascular Events [ Time Frame: 1 year ]
    Percentage of participants experiencing myocardial infarction, stroke or heart failure re-hospitalization

  3. Neurologic Status [ Time Frame: 1 year ]
    Average participant neurologic status, as determined by the Cerebral Performance Category instrument

  4. Health-related Quality of Life [ Time Frame: 1 year ]
    Average participant health-related quality of life score, using the Rand 36-Item Short Form Survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with cardiogenic shock at one of four high-volume North American quaternary care centers (Inova Heart and Vascular Institute, Sentara Norfolk General Hospital, University of Toronto and University of Utah)
Criteria

Inclusion Criteria:

  • Primary diagnosis of cardiogenic shock at time of index evaluation; including acute myocardial infarction- and acute decompensated heart failure-cardiogenic shock phenotypes
  • Patients with cardiac arrest complicating cardiogenic shock and those with massive pulmonary embolism with right ventricular cardiogenic shock will also be eligible for the registry

Exclusion Criteria:

  • Patients with shock not due to primary cardiac etiology will be excluded. These include septic, hemorrhagic, and anaphylactic shock.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05185492


Contacts
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Contact: John Kirk 801-585-2944 john.kirk@hsc.utah.edu

Locations
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United States, Florida
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
Contact: Maria Mejia    954-659-5637    Mejiagm@ccf.org   
Principal Investigator: David Baran, M.D.         
United States, Virginia
Inova Heart and Vascular Institute Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Bhruga Shah, MS    703-776-2828    Bhruga.Shah@inova.org   
Principal Investigator: Wayne Batchelor, MD         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada
Contact: Adriana Luk, M.D.    416-340-4800      
Principal Investigator: Adriana Luk, M.D.         
Sponsors and Collaborators
STAVROS G DRAKOS
Investigators
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Principal Investigator: Stavros Drakos, M.D. University of Utah
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Responsible Party: STAVROS G DRAKOS, Professor, Internal Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT05185492    
Other Study ID Numbers: IRB_00148867
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases