NCT05728359 Genomic Determinants of Outcome in Cardiogenic Shock
| NCT ID | NCT05728359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barts & The London NHS Trust |
| Condition | Cardiogenic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-08-08 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-08-08 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Alastair Proudfoot
PRINCIPAL INVESTIGATOR
Barts Heath NHS trust
Frequently Asked Questions
Who can join the NCT05728359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728359 currently recruiting?
Yes, NCT05728359 is actively recruiting participants. Contact the research team at alastair.proudfoot1@nhs.net for enrollment information.
Where is the NCT05728359 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05728359 clinical trial?
NCT05728359 is sponsored by Barts & The London NHS Trust. The principal investigator is Alastair Proudfoot at Barts Heath NHS trust. The trial plans to enroll 300 participants.