Genomic Determinants of Outcome in Cardiogenic Shock
ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBarts & The London NHS Trust
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
All patients presenting to recruiting sites who fulfil study inclusion criteria and have no exclusion, will be considered. The majority of patients will be present through the heart attack centres and pathways. Some patients will, however, develop cardiogenic shock (CS) during their admission. These patients will be recruited from the coronary care units, intensive care units or cardiology wards and will be identified by clinicians who will alert research staff.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study
Other interventionBlood sampling and clinical data collection
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: Cardiogenic shock and MI1 intervention
Group B: Cardiogenic shock and MI wtih ECMO1 intervention
Group C: Cardiogenic shock and MI wtih Impella1 intervention
Group D: MI without cardiogenic shock1 intervention
Group E: Non ischemic Cardiogenic Shock ie myocarditis1 intervention
Trial outcomes
Primary outcomes
1
The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality
This will be achieved through bloods sample collection, analysis and linked to the patient's clinical diagnosis and outcome.
Time frame
through study completion, an average of 5 daysSecondary outcomes
1
Identify transcriptomic (and chemokine/cytokine) signatures at presentation that elucidate the pathobiology of CS and examine their subsequent evolution.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Time frame
through study completion, an average of 5 days2
Correlate recently identified clinical phenotypes of CS with transcriptomic and inflammatory mediator signatures.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Time frame
through study completion, an average of 5 days3
Identify transcriptomic and chemokine/cytokine signatures at presentation that improve prognostic accuracy in patients with CS
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Time frame
through study completion, an average of 5 days4
Investigate inter-individual heterogeneity in the dynamic transcriptomic response to CS through an eQTL mapping approach and identify context- specific regulatory genetic variants involving gene networks central to the pathogenesis of CS.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Time frame
through study completion, an average of 5 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Barts & The London NHS Trust
Lead sponsor
University of Oxford
Collaborator
Source ClinicalTrials.gov