Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)

NCT07597291 | Not Yet Recruiting

• 1 other identifier: HSantaCruz
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluate the clinical outcomes and management approaches of cardiogenic shock throughout the years in adult patients admitted to a Cardiology Department. The main questions it aims to answer are:

• How have management strategies and clinical outcomes for cardiogenic shock evolved over time?
• How do clinical, laboratory, and advanced hemodynamic monitoring parameters relate to patient survival and overall prognosis in this population? Researchers will evaluate clinical data collected from 2017 onwards to see if therapeutic advancements and changes in clinical management over the years have led to improved patient survival and quality of care. Participants will:
• Receive standard, routine medical care for cardiogenic shock as determined by their clinical team (no experimental interventions will be introduced).
• Have their clinical, laboratory, and imaging data collected from hospital electronic records during their stay.
• Be followed for up to 1 year after hospital admission to evaluate long-term survival and clinical outcomes.

Conditions

Cardiogenic Shock Acute; Cardiogenic Shock; Cardiogenic Shock Post Myocardial Infarction

Keywords

Cardiogenic Shock; Shock, Cardiogenic; Hemodynamic Monitoring; Pulmonary Artery Catheterization; Swan-Ganz; Mechanical Circulatory Support; Prognosis; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality at 30 days after admission

  The proportion of patients presenting with cardiogenic shock who die from any cause during the first 30 days after admission

  From date of hospital admission to 30 days after admission

Secondary Outcomes (3)

• All-Cause Mortality at 1 Year

  At 1 year post-index admission.

• Incidence of Major Bleeding up to 30 days after admission

  From date of hospital admission to 30 days after admission

• Incidence of 3-Point Major Adverse Cardiovascular Events (3P-MACE) at 30 days

  From date of hospital admission to 30 days after admission

Other Outcomes (1)

• Rate of Long-term Ventricular Assist Device (LVAD) Implantation or Heart Transplantation

  Up to 1 year post-index admission.

Study Arms (1)

Cardiogenic Shock Registry Cohort

Adult patients admitted with a diagnosis of cardiogenic shock between January 2017 and the end of the prospective recruitment period. All patients receive contemporary, standard clinical management for cardiogenic shock as determined by the clinical team, with no experimental interventions. Clinical, laboratory, imaging, and advanced hemodynamic monitoring data are systematically collected from hospital records to evaluate clinical performance and outcomes over time.

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

The study population consists of adult patients admitted with cardiogenic shock. The population reflects a real-world, highly complex, and critically ill cohort comprising both a retrospective cohort (admitted from January 2017 onwards) and a prospective cohort consecutively enrolled at the center.

You may qualify if:

• Cardiogenic shock according to the following criteria:
• Cardiac disorder resulting in hypotension, defined as at least one of the following:
• Systolic blood pressure (SBP) \<90 mmHg for ≥30 minutes, or
• Requirement for vasopressors, inotropes, or mechanical circulatory support to maintain SBP ≥90 mmHg
• AND
• Evidence of tissue hypoperfusion, defined by the presence of at least one of the following:
• Serum lactate \>2 mmol/L
• Acute kidney injury and/or oliguria
• Acute hepatic injury
• Cool or mottled extremities
• Altered mental status
• AND
• Clinical presentation judged to be primarily attributable to a cardiac etiology.

You may not qualify if:

• Age \< 18 years.
• Other primary etiologies of shock at presentation (e.g., hypovolemic, hemorrhagic, septic, obstructive shock due to acute pulmonary embolism, or anaphylactic shock).
• Refusal to participate in the study (applicable only to the prospective cohort).

Sponsors & Collaborators

• Hospital de Santa Cruz, Portugal: lead

Related Publications (8)

• Kapur NK, et al. Mechanical circulatory support in cardiogenic shock. J Am Coll Cardiol. 2020.

  BACKGROUND

• Garan AR, et al. Complete hemodynamic profiling in cardiogenic shock. J Am Coll Cardiol. 2020.

  BACKGROUND

• Monnet X, Messina A, Greco M, Bakker J, Aissaoui N, Cecconi M, Coppalini G, De Backer D, Edul VK, Evans L, Hernandez G, Hunsicker O, Ince C, Kaufmann T, Levy B, Malbrain MLNG, Mebazaa A, Myatra SN, Ostermann M, Pinsky MR, Saugel B, Savi M, Singer M, Teboul JL, Vieillard-Baron A, Vincent JL, Chew MS. ESICM guidelines on circulatory shock and hemodynamic monitoring 2025. Intensive Care Med. 2025 Nov;51(11):1971-2012. doi: 10.1007/s00134-025-08137-z. Epub 2025 Nov 14.

  PMID: 41236566 BACKGROUND

• Krychtiuk KA, Vrints C, Wojta J, Huber K, Speidl WS. Basic mechanisms in cardiogenic shock: part 1-definition and pathophysiology. Eur Heart J Acute Cardiovasc Care. 2022 Jun 7;11(4):356-365. doi: 10.1093/ehjacc/zuac021.

  PMID: 35218350 BACKGROUND

• Thiele H, Ohman EM, de Waha-Thiele S, Zeymer U, Desch S. Management of cardiogenic shock complicating myocardial infarction: an update 2019. Eur Heart J. 2019 Aug 21;40(32):2671-2683. doi: 10.1093/eurheartj/ehz363.

  PMID: 31274157 BACKGROUND

• Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.

  PMID: 24419737 BACKGROUND

• van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.

  PMID: 28923988 BACKGROUND

• Hochman JS, et al. Cardiogenic shock complicating acute myocardial infarction-etiologies, management and outcome. N Engl J Med. 1999.

  BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

João Presume, MD

CONTACT

+351 21 043 1000; jppereira@ulslo.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share