Status:
UNKNOWN
Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
European Commission
University of Glasgow
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Cardiogenic shock (CGS) affects up to 10% of patients suffering acute coronary syndrome. It has a 30 day mortality of 45-50%. No pharmacological nor intervention/device trials have had any impact on t...
Detailed Description
The EURO SHOCK trial tests the novel use of early deployment of mechanical support device in Cardiogenic Shock (CGS) in a randomised, strategy trial, with evidence of benefit or otherwise measured by ...
Eligibility Criteria
Inclusion
- Willing to provide informed consent/assent.
- Presentation CGS within 24 hours of onset of Acute Coronary Syndrome (ACS) symptoms.
- CGS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or secondary to ACS following previous recent PCI (acute/sub-acute stent thrombosis ARC)
- PCI has been attempted.
- Persistence of CGS 30 minutes after successful or unsuccessful revascularisation of culprit coronary artery to allow for echocardiography and clinical assessment.
- CGS will be defined by the following 2 criteria:
- • Systolic blood pressure \<90 mmHg for at least 30 minutes, or 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.
- Provision of informed assent followed by patient consent; \[or relative or physician consent if the patient is unable to consent\].
Exclusion
- Unwilling to provide informed assent/consent.
- Echocardiographic evidence) of mechanical cause for CGS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation (recorded within 30 mins of end of PCI procedure).
- Age \<18 and\>90 years.
- Deemed appropriately frail (≥ 5 Canadian frailty score)
- Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, myocarditis etc.).
- Significant systemic illness
- Known dementia of any severity.
- Comorbidity with life expectancy \<12 months.
- Severe peripheral vascular disease (precluding access making ECMO contra- indicated).
- Severe allergy or intolerance to pharmacological or antithrombotic anti-platelet agents.
- Out-of-hospital cardiac arrest (OHCA) under any of the following circumstances:-
- without return of spontaneous circulation (ongoing resuscitation effort).
- without pH or \>7 without bystander CPR within 10 minutes of collapse.
- Involved in another randomised research trial within the last 12 months.
- Arterial lactate level of \<2.0 mmol per litre.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT03813134
Start Date
October 11 2019
End Date
February 1 2024
Last Update
May 3 2021
Active Locations (47)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090
2
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium, 9300
3
Onze Lieve Vrouw Hospital Aalst
Aalst, Belgium, 9300
4
University Hospital Antwerpen
Antwerp, Belgium, 2610