Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock

NCT05185492 | Recruiting DMC

• 1 other identifier: IRB_00148867
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cardiogenic Shock; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Survival

  Percentage of participants alive at analysis time points

  1 year

Secondary Outcomes (4)

• Vascular Complications

  1 year

• Major Adverse Cardiovascular and Cerebrovascular Events

  1 year

• Neurologic Status

  1 year

• Health-related Quality of Life

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• STAVROS G DRAKOS: lead

Study Sites (3)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

RECRUITING

University of Toronto

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Stavros Drakos, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Kirk

CONTACT

801-585-2944; john.kirk@hsc.utah.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: May 25, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)