Recruiting

Observational Study

Sponsor:

STAVROS G DRAKOS

Code:

NCT05185492

Conditions

Cardiogenic Shock

Acute Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05185492

Start date

May 25, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Survival [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

John Kirk

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

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Diana Yanez, BSN, RN

954-659-5570YANEZD@ccf.org

Principal Investigator:

David Baran, M.D.

Inova Heart and Vascular Institute

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Juan Carlos Ojeda

703-776-3779Juancarlos.Encisoojeda@inova.org

Principal Investigator:

Wayne Batchelor, MD

University of Toronto

Recruiting

Toronto, Ontario, Canada

Contacts

Adriana Luk, M.D.

416-340-4800Adriana.luk@uhn.ca

Principal Investigator:

Adriana Luk, M.D.

More Information

Sponsor

STAVROS G DRAKOS

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by STAVROS G DRAKOS on 2026-03-20.