Clinical trial NCT05185492: Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock
Official title: Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Acute Myocardial Infarction
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility 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.

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: Vascular Complications
timeFrame: 1 year
measure: Major Adverse Cardiovascular and Cerebrovascular Events
timeFrame: 1 year
measure: Neurologic Status
timeFrame: 1 year
measure: Health-related Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Utah
name: Stavros Drakos, M.D.
role: PRINCIPAL_INVESTIGATOR
References: