Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.


Options:
A: Inclusion Criteria:

* Acute myocardial infarction
* Cardiogenic shock

Exclusion Criteria:

* Absent peripheral pulses
* Mechanical complications of myocardial infarction
B: 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 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 \> 30 minutes
* Cerebral deficit with fixed dilated pupils
* No intrinsic heart action
* Mechanical infarction complication
* Onset of shock \> 12 h
* Severe peripheral artery disease
* Aortic regurgitation \> II.°
* Age \> 90 years
* shock of other cause
* Other severe concomitant disease
* participation in another trial
C: Inclusion Criteria:

* Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
* Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
* At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
* Written informed consent

Exclusion Criteria:

* Age \< 21 years
* Any contraindication to low molecular weight heparin
* Hemorrhagic stroke within the last 12 months
* Indication for anticoagulation other than ACS.
* Pregnancy or women of childbearing potential who are not using an effective method of contraception
* Co-morbid condition with life expectancy less than 6 months
* Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
D: Inclusion Criteria:

* Acute coronary syndrome (ACS/AMI) \< 48h and cardiogenic shock defined as:

  * Clinical criteria: Hypotension (syst.BP \< 90 mmHg and HR \> 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB \> 90mm Hg)and end-organ hypoperfusion
  * Hemodynamic criteria: CI \< 2.2 L/min/qm and a PCWP \> 15 mmHg or an EF of LV \< 30% and LVEDP \> 20 mmHg.
* Written informed consent of the patient or his/hers relatives

Exclusion Criteria:

* Age \< 18 years
* Prolonged Resuscitation (\> 30min)
* Hypertrophic Obstructive Cardiomyopathy
* Thrombus in left ventricle
* Treatment with IABP
* Severe valvular disease or mechanical heart valve
* Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation \>II°, rupture of the ventricle
* Failure of the right ventricle defined as the need for a RV Assist Device
* Septic condition
* Cerebral Disease
* Bleeding with a need for surgical intervention
* Pulmonary embolism
* Allergy to Heparin or any known coagulopathy
* Aortic regurgitation \>II°
* Pregnancy
* Inclusion in another study or trial

Answer: B