Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT01633502
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. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
3. Severe aorta valve regurgitation/stenosis.
4. Predominant right ventricular failure.
5. Out of hospital cardiac arrest with persistent Glasgow coma scale \<8 after return of spontaneous circulation.
6. Shock duration\>24 hours.
7. Known heparin intolerance.
8. Already established mechanical circulatory support
9. Do not resuscitate wish.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01633502
Study Brief:
Protocol Section:
NCT01633502