Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.


Options:
A: Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

* intended revascularization (PCI or CABG)
* Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole
* Signs of left heart insufficiency and pulmonary congestion
* Signs of impaired organ perfusion with at least one of the following:

  * Altered mental status
  * Cold, clammy skin
  * Urine output \<30 ml/h
  * Serum lactate \>2mmol/l
* Informed consent

Exclusion Criteria:

* Resuscitation \> 60 minutes, ischemia \> 10 minutes
* No intrinsic heart action
* Cerebral deficit with fixed dilated pupils
* Mechanical infarction complication
* Onset of shock \> 12 h
* Severe peripheral artery disease
* Aortic regurgitation \> II.°
* Age \> 80 years
* shock of other cause
* Other severe concomitant disease
* participation in another trial
B: Inclusion Criteria

* Age ≥ 18 and \< 75, men and women;
* 1) SBP \< 90mmHg or MAP \< 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg.
* Pre-existing diagnosis of heart failure with reduced ejection fraction (left ventricle systolic function ≤35%).
* Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: mixed venous oxygen saturation \< 60%; arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
* Eligible patients shouldn't have contraindications to HRT.

Exclusion Criteria

* Cardiogenic shock symptoms beyond 6 hours.
* Septic shock with evident septic focus.
* Cardiogenic shock due to acute myocardial infarction.
* Cardiogenic shock due to acute myocarditis.
* Cardiogenic shock due to pulmonary thromboembolism.
* Reiterating major arrhythmias: VT or VF or AF, with ventricular rate \> 160 bpm.
* Severe aortic valve disease.
* Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease
* Severe peripheral vascular disease that contraindicates mechanical support insertion.
* Cardiogenic shock secondary to either cardiac or non-cardiac surgery.
* Post-cardiac arrest syndrome following out of hospital cardiac arrest
* Comorbidities with ominous prognosis (life expectancy \< 1 year).
* End-stage organ failure.
* Pregnant, lactating or subjects planning pregnancy during the course of the trial.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
C: Inclusion Criteria:

1. ≥18 - ≤70 years
2. Witnessed OHCA (by bystanders)
3. Initial rhythm of VF/VT or AED administered
4. Bystander BLS

Exclusion Criteria:

1. ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery
2. Terminal heart failure (NYHA III or IV)
3. Severe pulmonary disease (COPD GIII of GIV)
4. Disseminated oncological disease
5. Obvious or suspected pregnancy
6. Bilateral femoral bypass surgery
7. Known contraindications for ECPR
8. Known pre-arrest CPC-score of 3 or 4
9. Known limitations in therapy or a Do Not Resuscitate-order
10. Multitrauma (Injury Severity Score \>15)
11. Expected time-to-start cannulation \> 60 minutes
D: Inclusion Criteria:

1. Symptomatic heart failure at enrollment (American College of Cardiology \[ACC\]/American Heart Association \[AHA\] Stage C) due to ischemic or nonischemic dilated cardiomyopathy
2. On stable, evidence-based medical and device therapy for heart failure for 3 months prior to randomization \<a\> Pharmacological Therapy (as appropriate) \<i\> angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigators discretion \<ii\> beta blockers \<iii\> diuretics, aldosterone inhibitors \<b\> Ejection fraction \< or = to 35% while maintained on optimal medical therapy \<c\> Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) \<i\> If implanted with a CRT or CRT-D, it must be implanted \> or = to 3 months before randomization \<ii\> If currently eligible or anticipated eligibility with a CRT or CRT-D within 6 months, the patient should not be enrolled in the study

Specific Qualifying Characteristics

1. Six (6) minute walk of 150 - 450m
2. Peak VO2 for males: 10.0-20.0 ml/kg/min; Peak VO2 for females: 9.0-18.0 ml/kg/min
3. Left ventricular end diastolic diameter (LVEDD) \<85mm and index \<40mm/m2 (LVEDD/BSA)
4. Heart failure duration \> or = to 6 months

Exclusion Criteria:

Patient History

1. Heart failure due to a reversible condition
2. Hypertrophic obstructive cardiomyopathy (HOCM)
3. Left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or intravenous inotropes are required or the patient has end stage heart failure despite maintenance on best medical therapy
4. Myxoma
5. Active infection, sepsis, endocarditis, myocarditis or pericarditis
6. Myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, or implantable cardioverter defibrillator (ICD) or pacemaker implantation in the 3 months prior to entry
7. Positive pregnancy test for pre-menopausal female
8. Less than 18 years or \> or = to 75 years old
9. Hemoglobin level less than 10 gm/dL or creatinine \>2.5 mg/dL
10. Uncontrolled medical conditions that increase surgical risk
11. Co-morbid condition that in the investigator's opinion reduces life expectancy to less than 2 years

Surgical or Anatomical Considerations

1. Heart measurement too large or small for Implant sizes
2. Restrictive cardiomyopathy
3. Not a candidate for sternotomy or standard thoracotomy surgical approaches
4. Expected to have adhesions from previous surgical procedures
5. History of constrictive pericarditis
6. Previously placed coronary artery bypass grafts (CABG) or anticipated need for coronary artery bypass grafting
7. Not a candidate for cardiopulmonary bypass
8. Anatomical mitral valve regurgitation of 2+ or greater at the time of enrollment
9. Pulmonary function testing with the following results: Forced expiratory volume (FEV1) \<1L or if FEV1 is between 1 and 3L, forced expiratory volume divided by forced vital capacity (FEV1/FVC) \<60%
10. Cardiac or thoracic condition that might require operative correction. Cardiac transplantation is not included in this exclusion criterion.
11. Other elective surgical procedure at the time of the index hospitalization or within 30 days, whichever is longer

Other

1. Any other medical condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure
2. Currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
3. Unwilling/unable to comply with follow-up
4. Unwilling/unable to give signed informed consent

Answer: A