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Genomic Determinants of Outcome in Cardiogenic Shock

Sponsor: Barts & The London NHS Trust

NCT ID: NCT05728359

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Observational study (other)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
Observational study — other: Blood sampling and clinical data collection
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 80 Years
Who
All
Number of participants
300
Started
2022-08-08
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiogenic shock
  • • Clinical study - 300 participants
  • • The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with cardiogenic shock

Where?

  • • London - Barts Health NHS trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Cardiogenic Shock

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

met

Treatment history

Treatments you must have had:

  • ✓ for inclusion following screening:

What the study is looking for

  • ✓All of the following are required for inclusion following screening:
  • ✓Willing to provide agreement to take part 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

Who cannot take part

  • ✗Any of the inclusion criteria not met and:
  • ✗Unwilling to provide agreement to take part.
  • ✗Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg...
  • ✗Age \<18 and ≥80 years.
  • ✗Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
See the full criteria
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.

Where Is This Study? (1 UK site)

Barts Health NHS trust

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Alastair Proudfoot

Sponsor contact

CONTACT

02037658707 alastair.proudfoot1@nhs.net

Mervyn Andiapen

Sponsor contact

CONTACT

02037658707 mervyn.andiapen@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-11