Outcomes for people with cardiogenic shock after myocardial infarction by comparing two blood pressure targets.

Phase 1

• Conditions: Myocardial infarction related cardiogenic shock; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005551-36-DK
• Lead Sponsor: Amsterdam University Medical Center, AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-28
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 776

Inclusion Criteria

1. Acute myocardial infarction, STEMI or NSTEMI
2. Early revascularization by PCI
3. Cardiogenic shock, characterized by:
I. 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 < 30ml/hour
d. Serum lactate > 2.0 mmol/L
II. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR
b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization.
III. Clinical signs of pulmonary congestion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

-Resuscitation > 30 minutes
- Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
- Onset of shock > 12 hours
- Imminent need for mechanical circulatory support
-Women < 45 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified