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Search / Trial NCT06886113

CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Launched by SHENZHEN CORE MEDICAL TECHNOLOGY CO.,LTD. · Mar 14, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Acute Myocardial Infarction

ClinConnect Summary

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 of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive CorVad, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days.The target population of subjects are patients with acute myocardial infarction with cardiogenic shock who need high-risk PCI treatment, and ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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
  • 2. 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
  • 3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.
  • Exclusion Criteria:
  • 1. Shock duration N24 hours
  • 2. Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
  • 3. Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
  • 4. Severe aorta valve regurgitation/stenosis
  • 5. Severe peripheral arterial obstructive disease that would preclude Impella device placement
  • 6. Mechanical aortic valve prosthesis
  • 7. Already established mechanical circulatory support (Impella or VA-ECMO)
  • 8. Left ventricular thrombus
  • 9. Infective endocarditis
  • 10. Shock due to right ventricular failure
  • 11. 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.
  • 12. Subject with documented heparin induced thrombocytopenia.
  • 13. Life expectancy of less than 1 year due to comorbidities.
  • 14. Mental disorder or language barrier that preclude informed

About Shenzhen Core Medical Technology Co.,Ltd.

Shenzhen Core Medical Technology Co., Ltd. is a leading clinical trial sponsor dedicated to advancing healthcare through innovative medical technologies and rigorous research methodologies. With a focus on developing cutting-edge diagnostic and therapeutic solutions, the company collaborates with healthcare professionals and research institutions to conduct high-quality clinical trials. Committed to ensuring patient safety and regulatory compliance, Shenzhen Core Medical Technology leverages its expertise to facilitate the efficient progression of new therapies from concept to market, ultimately aiming to enhance patient outcomes and contribute to the global medical landscape.

Locations

Hangzhou, Zhejiang, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported