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Cardiogenic Shock AcuteCOR-SHOCKNCT07597291

Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)

An observational study of Cardiogenic Shock Acute and Cardiogenic Shock, run by Hospital de Santa Cruz, Portugal at 1 site in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
800 participants
Where
1 sitePortugal
Study dates
10 Jun 2026to 31 Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • -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:
Show all 13Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Portugal1 site, 1 recruiting
  • Unidade Local de Saúde de Lisboa Ocidental

    Carnaxide, Lisbon District, 2790-134

    João Presume, MD, +351 21 043 1000, jppereira@ulslo.min-saude.pt

    Catarina Brízido, MD, +351 21 043 1000, cbrizido@ulslo.min-saude.pt

    Recruiting

Other trials in Portugal

About this study

Official title: Cardiovascular Outcomes Registry in Cardiogenic SHOCK

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?
Read more

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.
Read the detailed description

The Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK) is hybrid (retrospective and prospective), observational registry designed to evaluate the clinical performance, therapeutic management, and outcomes of patients presenting with cardiogenic shock (CS).

Contemporary CS management has evolved beyond correcting macro-hemodynamic parameters. CS is now recognized as a highly dynamic, systemic syndrome characterized by microvascular hypoperfusion, systemic inflammatory response syndrome (SIRS), endothelial dysfunction, and profound neurohormonal and metabolic derangements. To capture this complexity, the COR-SHOCK registry systematically integrates granular, real-world data reflecting these pathophysiological axes. This includes laboratory evaluation, and advanced invasive hemodynamic profiling via pulmonary artery catheterization (Swan-Ganz).

Registry Procedures and Quality Assurance Plan

To ensure high-quality data collection and compliance with scientific standards, the registry implements the following procedures:

  1. Quality Assurance (QA) Plan: The Steering Committee, led by the Principal Investigator, oversees the registry's operations. Internal data quality audits are conducted semi-annually to review enrollment rates, evaluate protocol adherence, and identify systematic data entry discrepancies.
  2. Data Checks: Data is transcribed from electronic health records into a dedicated electronic database. The entry platform utilizes programmed range validation and consistency rules (e.g., preventing physiological out-of-range values for hemodynamics and laboratory results, and enforcing logical chronological order for clinical events, such as ensuring discharge dates succeed admission dates).
  3. Source Data Verification (SDV): To guarantee data accuracy and completeness, a designated researcher who is not directly involved in the primary data entry performs random source data verification on 10% of all registry entries. This process involves cross-referencing database records with original paper and electronic health records.
  4. Data Dictionary: A comprehensive data dictionary has been established, detailing every variable collected. It defines clinical terminology, laboratory reference ranges, and standardized categorization rules.
  5. Standard Operating Procedures (SOPs): Formal SOPs govern all key registry processes, including:
  • Daily screening and identification of eligible patients in the cardiac intensive care unit (UNICOR).
  • Standardized timing for dynamic data collection.
  • Data security protocols, including patient pseudonymization and password-protected access control.
  • Event reporting protocols for predefined clinical complications.
  1. Sample Size Assessment:

The registry aims to include approximately 750 to 800 patients. This target is calculated based on historical admission rates at the center, comprising a retrospective cohort of approximately 500 patients (2017-2025) and a prospective recruitment target of 80 to 100 patients annually over a 2-to-3-year period. This sample size provides sufficient statistical power to characterize temporal trends, evaluate subset populations (e.g., mechanical circulatory support, specific etiologies), and perform robust multivariable risk modeling.

Statistical Analysis Plan (SAP) Descriptive statistics will characterize the study population. Continuous variables will be presented as mean ± standard deviation (SD) or median with interquartile range (IQR), based on normality (assessed via Shapiro-Wilk test). Categorical variables will be expressed as frequencies and percentages.

To evaluate management and outcome trends over the years:

  • Temporal trends in clinical management, therapeutic choices (such as the use of short-duration mechanical circulatory support [VA-ECMO, Impella, IABP] or advanced therapies [LVAD, cardiac transplantation]), and survival will be assessed using linear/logistic regression models across calendar years.
  • Survival curves will be estimated using the Kaplan-Meier method and compared across different clinical phenotypes, therapeutic interventions, and time epochs using the log-rank test.
  • Multivariable Cox proportional hazards regression and logistic regression models will be constructed to identify independent clinical, laboratory and hemodynamic predictors of short-term (ICU and in-hospital) and long-term (1 year) mortality. Model fit and calibration will be evaluated using standard diagnostic metrics (e.g., Harrell's C-index).
Keywords
Cardiogenic Shock, Shock, Cardiogenic, Hemodynamic Monitoring, Pulmonary Artery Catheterization, Swan-Ganz, Mechanical Circulatory Support, Prognosis, Myocardial Infarction
Medical subject headings
Shock, Cardiogenic, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07597291
Study groupRoleWhat they receive
Cardiogenic Shock Registry CohortAdult 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From date of hospital admission to 30 days after admission

Secondary outcomes (3)
  1. All-Cause Mortality at 1 Year

    The rate of all-cause mortality evaluated after the index admission. Survival status will be determined via electronic medical records or the national registry ("last seen alive" verification).

    Measured: At 1 year post-index admission.

  2. Incidence of Major Bleeding up to 30 days after admission

    The proportion of patients experiencing major bleeding events up to 30 days after admission. Major bleeding is defined according to the Bleeding Academic Research Consortium (BARC) classification as Type 3 (including 3a, 3b, and 3c) or Type 5 (fatal bleeding).

    Measured: From date of hospital admission to 30 days after admission

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

    Thrombotic/ischemic events are defined using the 3-point Major Adverse Cardiovascular Events (3P-MACE) composite, which includes cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke at 30 days after admission.

    Measured: From date of hospital admission to 30 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start10 Jun 2026
  3. Primary completion31 Dec 2036 (estimated)
  4. Study completion31 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07597291
Sponsor's protocol ID
HSantaCruz
Acronym
COR-SHOCK
Status last verified
Jun 2026
First submitted
9 May 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) will not be publicly shared to protect patient confidentiality and ensure strict compliance with legal and ethical standards. This study is conducted in accordance with the European Union General Data Protection Regulation (GDPR) and Portuguese Data Protection Law (Lei n.º 58/2019). De-identified, aggregated data or specific proposals for collaborative academic research may be considered upon reasonable request, subject to approval by the study's Steering Committee and the institutional Ethics Committee (contact via jppereira@ulslo.min-saude.pt).

Publications

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

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

  • 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.

    PubMed 41236566
  • 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.

    PubMed 35218350
  • 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.

    PubMed 31274157
  • 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.

    PubMed 24419737
  • 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.

    PubMed 28923988
  • Hochman JS, et al. Cardiogenic shock complicating acute myocardial infarction-etiologies, management and outcome. N Engl J Med. 1999.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock Acute and Cardiogenic Shock, run by Hospital de Santa Cruz, Portugal at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact João Presume, MD (+351 21 043 1000 ext. 3134, jppereira@ulslo.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality at 30 days after admission (time frame: From date of hospital admission to 30 days after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07597291, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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