Status:
NOT_YET_RECRUITING
CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
Lead Sponsor:
Shenzhen Core Medical Technology CO.,LTD.
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shoc...
Detailed Description
The study is a prospective, multicenter trial in patients with AMICS randomized 1:1 to CorVad or current guideline-driven therapy with planned enrollment of 269 patients. Patients comatose after out o...
Eligibility Criteria
Inclusion
- ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and
- Cardiogenic shock of less than 24 hours' duration, confirmed by:
- peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 \<55% with a normal PaO2) and systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and
- Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.
Exclusion
- Shock duration N24 hours
- Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
- Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
- Severe aorta valve regurgitation/stenosis
- Severe peripheral arterial obstructive disease that would preclude Impella device placement
- Mechanical aortic valve prosthesis
- Already established mechanical circulatory support (Impella or VA-ECMO)
- Left ventricular thrombus
- Infective endocarditis
- Shock due to right ventricular failure
- Out of hospital cardiac arrest with persistent Glasgow coma scale b8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.
- Subject with documented heparin induced thrombocytopenia.
- Life expectancy of less than 1 year due to comorbidities.
- Mental disorder or language barrier that preclude informed
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2028
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT06886113
Start Date
October 1 2025
End Date
February 15 2028
Last Update
March 20 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000