Genomic Determinants of Outcome in Cardiogenic Shock (Goldilocs)

November 17, 2025 updated by: Barts & The London NHS Trust

Prospective Observational Study Investigating Genomic Determinants of Outcome From Cardiogenic Shock (GOlDilOCS)

The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational cohort study in 8-10 cardiac centres across Europe. We will recruit patients presenting with acute myocardial infarction (AMI) and CS who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the Impella Device (n=50). We will also enrol patients who present with either AMI and no evidence of CS (n=50) or CS due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. The recruitment target is 300 patients.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All patients presenting to recruiting sites who fulfil study inclusion criteria and have no exclusion, will be considered. The majority of patients will be present through the heart attack centres and pathways. Some patients will, however, develop cardiogenic shock (CS) during their admission. These patients will be recruited from the coronary care units, intensive care units or cardiology wards and will be identified by clinicians who will alert research staff.

Description

Inclusion Criteria:

  • All of the following are required for inclusion following screening:

    • Willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee
    • Presentation within 24 hours of onset of ACS symptoms.
    • CS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or myocarditis
    • Planned or completed revascularisation of culprit coronary artery

CS will be defined by:

  • Systolic blood pressure <90 mmHg for at least 30 minutes
  • A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure > 90 mmHg.

  • Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:

    • altered mental status.
    • cold and clammy skin and limbs.
    • oliguria with a urine output of less than 30 ml per hour.
    • elevated arterial lactate level of >2.0 mmol per litre.

Exclusion Criteria:

  • Any of the inclusion criteria not met and:

    1. Unwilling to provide informed consent.
    2. Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation.
    3. Age <18 and ≥80 years.
    4. Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
    5. Significant systemic illness
    6. Known dementia of any severity
    7. Comorbidity with life expectancy <12 months.

    8. Out-of-hospital cardiac arrest (OHCA) and any of the following:

      1. No return of spontaneous circulation (ongoing resuscitation effort)
      2. pH <7
      3. Without bystander CPR within 10 minutes of collapse
    9. Arterial lactate level of <2.0 mmol per litre.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiogenic shock and MI
Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically (ie. inotropes +/- intra aortic balloon pump only). N=50
Other: Observational study
Blood sampling and clinical data collection
Cardiogenic shock and MI wtih ECMO
Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with ECMO (+/- LV unloading device). N=50
Other: Observational study
Blood sampling and clinical data collection
Cardiogenic shock and MI wtih Impella
Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with Impella. N=50
Other: Observational study
Blood sampling and clinical data collection
MI without cardiogenic shock
Patients presenting with acute myocardial infarction and cardiogenic shock as a control comparator
Other: Observational study
Blood sampling and clinical data collection
Non ischemic Cardiogenic Shock ie myocarditis
Patients presenting with myocarditis and cardiogenic shock as a control comparator
Other: Observational study
Blood sampling and clinical data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality
Time Frame: through study completion, an average of 5 days
This will be achieved through bloods sample collection, analysis and linked to the patient's clinical diagnosis and outcome.
through study completion, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify transcriptomic (and chemokine/cytokine) signatures at presentation that elucidate the pathobiology of CS and examine their subsequent evolution.
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days
Correlate recently identified clinical phenotypes of CS with transcriptomic and inflammatory mediator signatures.
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days
Identify transcriptomic and chemokine/cytokine signatures at presentation that improve prognostic accuracy in patients with CS
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days
Investigate inter-individual heterogeneity in the dynamic transcriptomic response to CS through an eQTL mapping approach and identify context- specific regulatory genetic variants involving gene networks central to the pathogenesis of CS.
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days
Identity novel therapeutic targets that might modulate the dysfunctional immune response to CS - "drug discovery"
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days
Determine the extent to which the signatures and drivers of a dysfunctional immune response in CS are shared with other critical illness syndromes.
Time Frame: through study completion, an average of 5 days
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
through study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

University of Oxford

Investigators

  • Principal Investigator: Alastair Proudfoot, Barts Heath NHS trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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