Genomic Determinants of Outcome in Cardiogenic Shock

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.

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:

• Unwilling to provide informed consent.
• 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.
• Age <18 and ≥80 years.
• Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
• Significant systemic illness
• Known dementia of any severity
• Comorbidity with life expectancy <12 months.
• Out-of-hospital cardiac arrest (OHCA) and any of the following:

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