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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSTAVROS G DRAKOS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Cardiogenic shock cohort

Trial outcomes

Primary outcomes

1

Survival

Percentage of participants alive at analysis time points

Time frame
1 year

Secondary outcomes

1

Vascular Complications

Percentage of participants experiencing stroke or need for renal replacement therapy

Time frame
1 year
2

Major Adverse Cardiovascular and Cerebrovascular Events

Percentage of participants experiencing myocardial infarction, stroke or heart failure re-hospitalization

Time frame
1 year
3

Neurologic Status

Average participant neurologic status, as determined by the Cerebral Performance Category instrument

Time frame
1 year
4

Health-related Quality of Life

Average participant health-related quality of life score, using the Rand 36-Item Short Form Survey

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

STAVROS G DRAKOS

Lead sponsor

University of Utah

Sponsor institution