Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.
Brief Summary: The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.


Options:
A: Inclusion Criteria:

* Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
* Revascularization by PCI,
* Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
* Dyspnoea at rest and one of the following:

pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.

Subgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.

Exclusion Criteria:

* Age below 20 years
* Heart rate above 120 bpm
* Septic shock
* ARDS
* Creatinine \>450 micromol/l
* Hepatic impairment
* Significant mechanical outlet obstruction
* Allergy against study drug medication
* Anaemia (Hb \<8 g/dl)
* Pregnancy
B: Men and women with myocardial infarction and cardiogenic shock.
C: Inclusion Criteria:

* Written, signed and dated informed consent
* Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal \[two years since last menstrual cycle\], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential
* Hospitalised patients with acutely decompensated heart failure
* Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months
* Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:

  * oliguria (mean urine output \< 30 ml/h for at least 6 hours) and not a result of hypovolemia
  * dyspnoea at rest or mechanical ventilation for heart failure
  * haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)

Exclusion Criteria:

* Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy
* Weight ≥ 160 kg
* Cardiac surgery within 30 days before screening
* Stroke within 3 months before screening
* Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
* Heart rate persistently 130 bpm or greater at screening or at baseline
* Serum potassium less than 3.5 mmol/l at screening
* Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation
* Hypersensitivity to levosimendan or dobutamine or any of their excipients
* A history of Torsades de Pointes
* Severe renal insufficiency (serum creatinine \> 450 mmol/l \[5.0 mg/dl\]) or on dialysis
* Significant hepatic impairment at discretion of the investigator
* Acute bleeding
* Severe anemia (haemoglobin \< 8 g/dl) at screening
* Septicaemia or septic shock
* Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
* Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
* Administration of levosimendan within 30 days prior to screening
D: Inclusion Criteria:

* Confirmed myocardial infarction (heart attack)
* Confirmed persistent cardiogenic shock
* Confirmed patency of the infarct related artery (heart attack artery has been opened through the use of a blood clot dissolving drug or a balloon or angioplasty heart procedure)
* Less than 24 hour duration of cardiogenic shock (the time since the heart attack occurred and the artery was opened must be less than 24 hours)

Exclusion Criteria:

* Infection
* Other cause of shock (not heart attack)
* Shock due to heart valve disease
* Severe heart valve disease
* Right sided heart failure
* Shock due to arrhythmia (irregular heart rhythm)
* Severe kidney disease
* Aortic dissection (tear in aorta)
* Adult respiratory distress syndrome (ARDS) (severe lung inflammation)
* Severe brain damage
* Severe irreversible multi-system failure (failure of multiple body organs)
* Major chest or abdominal surgical procedure within 30 days except if prior CABG and reocclusion occurs
* Primary pulmonary hypertension (high blood pressure in the arteries of the lungs)
* Age younger than 18 years
* Requirement for emergency coronary artery bypass grafting (CABG) or infarct-related artery occlusion (heart attack artery completely blocked)
* Ongoing or recent participation in another clinical trial of an investigational drug
* Prior enrollment in this study or rapid resolution of cardiogenic shock before treatment (shock gets better before study starts)
* Positive pregnancy test in women who are of childbearing potential

Answer: A