Understanding genetic factors in cardiogenic shock outcomes

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

This study is trying to see how genetic differences affect recovery and treatment success in patients with cardiogenic shock after a heart attack.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Barts & The London NHS Trust (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT05728359 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to investigate the variability in immune responses and treatment outcomes in patients with cardiogenic shock (CS) following acute myocardial infarction. Conducted across 8-10 cardiac centers in Europe, the study will recruit a total of 300 patients, including those supported by medical treatment, extracorporeal membrane oxygenation (ECMO), and the Impella device. By identifying transcriptomic sub-phenotypes, the study seeks to correlate these genetic factors with patient outcomes and therapeutic responses.

Who should consider this trial

Good fit: Ideal candidates include patients presenting with acute myocardial infarction and cardiogenic shock within 24 hours of symptom onset.

Not a fit: Patients with cardiogenic shock not related to acute coronary syndrome or myocarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients experiencing cardiogenic shock.

How similar studies have performed: Other studies have explored genetic determinants in cardiovascular conditions, but this specific approach to cardiogenic shock is relatively novel.

Eligibility 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 this trial is running

London

• Barts Health NHS trust — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Alastair Proudfoot — Barts Heath NHS trust
• Study coordinator: Alastair Proudfoot

Conditions Cardiogenic Shock; ACS,; ECMO; Impella; Gene Expression; Endotype