Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, 2x2 factorial interventional study compares four treatment strategies for acute myocardial infarction with cardiogenic shock. It evaluates immediate mechanical circulatory support with a microaxial flow pump (Impella) after PCI, and protocol-based hemodynamic monitoring using a pulmonary artery catheter, versus conventional monitoring. Participants are assigned to one of four combinations to see if mechanical support and/or advanced monitoring reduce mortality. Outcomes focus on survival and hemodynamic stabilization in AMI-CS patients. The trial is conducted with multiple collaborators led by Leipzig Heart Science gGmbH.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:

1. Planned immediate angiography and revascularization (preferred PCI)
2. Systolic blood pressure \<100 mmHg or catecholamines required to maintain pressure \>90 mmHg during systole
3. Arterial lactate \>2.0 mmol/L
4. Echocardiogram with LVEF \<40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm

Exclusion Criteria:

1. Age \<18 and \>80 years
2. Shock duration \>12 hours
3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
4. Shock due to mechanical complication of AMI
5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \<10 min are also eligible)
6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion
7. Any unwitnessed OHCA
8. Refractory cardiac arrest with ongoing chest compression
9. Evidence of severe right ventricular failure
10. Severe aorta valve regurgitation/stenosis
11. Severe peripheral arterial obstructive disease precluding mAFP placement
12. Abnormalities of the aorta precluding mAFP device placement
13. Presence of a mechanical aortic valve prosthesis
14. Left ventricular thrombus
15. Infective endocarditis
16. Life expectancy \<1 year due to comorbidities
17. Mental disorder or language barrier that preclude informed consent
18. Known pregnancy

Where it's running

• Heart Center Leipzig at University of Leipzig
  Leipzig, Saxony, Germany Recruiting

Study contacts

• Principal investigator: Holger Thiele, Prof. Dr. med. — Heart Center Leipzig at University of Leipzig
• Study coordinator: DOUBLE SHOCK Leipzig Heart Science gGmbH
• Email: DOUBLE-SHOCK@leipzig-heart.de
• Phone: +49 341 865 251542

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.