Understanding genetic factors in cardiogenic shock outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barts Health NHS trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Alastair Proudfoot — Barts Heath NHS trust
• Study coordinator: Alastair Proudfoot
• Email: alastair.proudfoot1@nhs.net
• Phone: 02037658707

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors Influencing Outcomes in ECMO and Impella Patients

  This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.

  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

  This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07769528

• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

  In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07762560

• CRP Apheresis for infarct-related cardiogenic shock

  This study tests whether selectively removing C-reactive protein with apheresis, in addition to standard care, helps people with cardiogenic shock after a heart attack.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07687017

• Compare two ventilator modes in adults with cardiac ICU needs and invasive ventilation

  This pilot tests whether volume-controlled versus pressure-controlled ventilation can be safely used in adults with heart disease and respiratory failure who need invasive ventilation.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07656259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.