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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT02697006
Eligibility Criteria:
Inclusion Criteria:
Patients in cardiogenic shock in the setting of acute myocardial infarction
or
Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.
Cardiogenic shock is defined as
* Systolic blood pressure \< 90 mmHg for at least 30 min or
* Inotropes are needed to maintain blood pressure \> 90 mmHg or
* Clinical signs of heart insufficiency with pulmonary congestion or
* Signs of end organ hypoperfusion with at least one of the following criteria:
* Altered mental status
* cold, damp skin or extremities
* oliguria (≤ 30 mL/h)
* serum lactate \> 2.0 mmol/L
Written consent of the patient or the legal caregiver
\-
Exclusion Criteria:
* Age \> 85 years
* Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 10 min
* Coma with fixed pupils not induced by drugs;
* Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
* Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
* Fever (Body temperature \> 38.0 °C) or other evidence of sepsis
* Onset of cardiogenic shock \> 6 h before enrollment;
* Lactate \> 22 mmol/L;
* Massive pulmonary embolism;
* Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
* Previous known aortic regurgitation greater than grade II
* Contra-indications for anticoagulation
* Severe hemolysis of any cause
* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02697006
Study Brief:
Protocol Section:
NCT02697006