Prospective randomized multicenter study comparing immediate multivessel revascularization by PCI versus culprit lesion PCI with staged non-culprit lesion revascularization in patients with acute myocardial infarction complicated by cardiogenic shock

Withdrawn

• Conditions: cardiac disease; Coronary artery disease; 10011082

• Registration Number: NL-OMON45167
• Lead Sponsor: niversity of Lubeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with
obligatory:;1. Planned early revascularization by PCI;2. Multivessel coronary artery disease defined as >70% stenosis in at least 2 major
vessels (>=2 mm diameter) with identifiable culprit lesion;3. a Systolic blood pressure <90 mmHg for >30 min or
b catecholamines required to maintain pressure >90 mmHg during systole and;4. Signs of pulmonary congestion;5. Signs of impaired organ perfusion with at least one of the following criteria
a) Altered mental status
b) Cold, clammy skin and extremities
c) Oliguria with urine output <30 ml/h
d) Serum-lactate >2.0 mmol/l;6. Informed consent

Exclusion Criteria

1. Resuscitation >30 minutes;2. No intrinsic heart action;3. Cerebral deficit with fixed dilated pupils (not drug-induced);4. Need for primary urgent bypass surgery (to be determined after diagnostic angiography);5. Single vessel disease;6. Mechanical cause of cardiogenic shock;7. Onset of shock >12 h;8. Massive lung emboli;9. Age >90 years;10. Shock of other cause (bradycardia, sepsis, hypovolemia, etc.);11. Other severe concomitant disease with limited life expectancy <6 months;12. Pregnancy;13. Known severe renal insufficiency (creatinine clearance <30 ml/kg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>30-day mortality and/or severe renal failure requiring renal replacement<br /><br>therapy [ Time Frame: 30 days ] </p><br>