Please select the eligibility criteria that correspond to the clinical trial below.
Title: Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease
Brief Summary: Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy


Options:
A: Inclusion Criteria:

* Patients with chronic ischemic heart disease
* Patients with anterior myocardial infarction \> 3months
* EF \< 50% or NYHA II-IV
* Age 18-80
* Informed consent

Exclusion Criteria:

* Ventricular thrombus
* Infarct \< 3 months.
* Active infection or fever
* Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
* HIV Infection oder active Hepatitis
* Neoplastic disease w/o complete remission within 5 years
* Stroke \< 3months
* Creatinine \> 2 mg/dl
* Relevant Liver disease (GOT \> twice the upper limit).
* Anemia (Hemoglobin \<10 mg/dl)
* Thrombocytopenia \< 100.000/µl
* Allergies to Aspirin, Clopidogrel, Heparin
* History of bleeding disorder
* History of coagulopathy
* Gastrointestinal Bleeding \< 3 months
* Surgery or Trauma \< 2 months
* Pregnancy
* Mental Retardation
* Participation in other clinical study \< 1 month
B: Inclusion Criteria:

* Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation;
* Age 18 years or older;
* If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure;
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening;
* Admitted to the clinical center at the time of randomization;
* Clinical indication and accepted candidate for implantation of an FDA approved implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

* Planned percutaneous LVAD implantation;
* Anticipated requirement for biventricular mechanical support;
* Cardiothoracic surgery within 30 days prior to randomization;
* Myocardial infarction within 30 days prior to randomization;
* Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty;
* Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism);
* Stroke within 30 days prior to randomization;
* Platelet count \< 100,000/ul within 24 hours prior to randomization;
* Active systemic infection within 48 hours prior to randomization;
* Presence of \>10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
* A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products;
* History of cancer prior to screening (excluding basal cell carcinoma);
* Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
* Received investigational intervention within 30 days prior to randomization;
* Treatment and/or an incompleted follow-up treatment of any investigational cell based therapy within 6 months prior to randomization;
* Active participation in other research therapy for cardiovascular repair/regeneration;
* Prior recipient of stem precursor cell therapy for cardiac repair;
* Pregnant or breastfeeding at time of randomization.
C: Inclusion Criteria:

* Symptomatic patients with a diagnosis of heart failure secondary to ischaemic heart disease who are on optimal heart failure treatment and no further treatment options available
* Patient has been considered for an implantable defibrillator in keeping with NICE guidelines

Exclusion Criteria:

* Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
* The presence of cardiogenic shock
* The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
* Known severe pre-existent left ventricular dysfunction (ejection fraction \< 10% prior to randomisation)
* Congenital cardiac disease
* Cardiomyopathy secondary to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
* Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
* Contra-indication for bone marrow aspiration
* Known active infection
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) syphilis or HTLV
* Lifestyle with high risk for infection with HIV, HBV or HCV syphilis or HTLV
* Serum creatinine \>200 umol/L
* Chronic inflammatory disease
* Serious known concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc)
* Previous participation in this study
* Female subjects of childbearing potential
* Atrial fibrillation
* Patients who have responded to the implantation of a biventricular pacemaker
* Weight \>140kg
D: Inclusion Criteria:

* General (patients must have all)

  * Symptomatic heart failure.
  * Scheduled to CABG
  * Be 18 to 75 years of age
  * Informed Consent obtained
* Heart Failure Presentation

  * Patients of either gender, who has evaluated in cardiovascular laboratory and scheduled to CABG with moderate heart failure, will be eligible
  * NYHA II-IV symptoms
  * Left ventricular ejection fraction in screening echocardiography 15 to 45%.
  * Optimal heart failure medication and coronary medication before operation, containing at least two heart failure drugs: must have ACE-inhibitor, or AT II blocker, and/or b-blocker together with diuretics, digitalis or aldosterone antagonist, and coronary medication: a statin and anticoagulation, either aspirin or clopidogrel.

Exclusion Criteria:

* Heart failure due to left ventricular outflow track obstruction (valve problem or HOCM)
* History of life-threatening ventricular arrhythmias or resuscitation, condition which may be repeatable or implanted ICD.
* Stroke or other disabling condition with in 3 months before screening
* Contraindications to coronary angiogram or MRI
* Other serious disease limiting life expectancy
* Participation in an other clinical trial
* Severe valve disease: mitral, aortic, tricuspid or pulmonic stenosis / insufficiency
* Scheduled valve operation

Answer: A