Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Inclusion Criteria:

* Female or male inpatients
* Age: 18 - 80 years.
* Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
* Onset of symptoms between 3 and 4 hours prior to initiation of administration of study drug.
* Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder.
* Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
* Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are willing to participate voluntarily and must be able to understand an explanation of the contents of he information sheet.
* Willingness and ability to comply with the protocol.

Exclusion Criteria:

* Evidence of intracranial hemorrhage (ICH) on the CT-scan.
* Symptoms of ischaemic attack began more than 4 hours and 30 minutes prior to infusion start or when time of symptom onset is unknown.
* Minor neurological deficit or symptoms rapidly improving before start of infusion.
* Severe stroke as assessed clinically (e.g. NIHSS\>25) and/or by appropriate imaging techniques.
* Epileptic seizure at onset of stroke
* Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal.
* Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
* History of prior stroke and concomitant diabetes. \* Prior stroke within the last 3 months
* Platelet below 100,000/mm3. \* Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits.
* Blood glucose \<50 or \> 400 mg/dl (\< 2.77 or \> 22.15 mmol / l). \* Known haemorraghic diathesis
* Patients receiving oral anticoagulants. \* Manifest or recent severe or dangerous bleeding
* Known history of or suspected intracranial haemorrhage
* Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
* History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
* Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
* Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture.
* bacterial endocarditis, pericarditis.\* Acute pancreatitis
* Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation
* Neoplasm with increased bleeding risk
B: Inclusion Criteria:

* Age 18-85 years old.
* Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
* Signed, documented informed consent prior to admission to the study.

Exclusion Criteria:

* Urgent or emergent bypass required to be performed \<24 hrs after screening.
* Unstable angina, requiring intervention or CABG \<24 hrs after screening.
* Decompensated congestive heart failure.
* Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
* Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
* Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.
* Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
* Patients who are pregnant or nursing.
* Patients unable to provide/sign informed consent.
* Patients currently enrolled in another clinical trial without a 30 day washout period.
* Patients currently taking marine based omega-three fish oil supplements.
C: Inclusion Criteria:

* ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
* 18 years or older
* written informed consent

Exclusion Criteria:

* Primary prophylactic indication
* ICD implantation as a 'bridge' to heart transplantation
* Refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy
* a projected lifespan of less than 1 year
* participation in another trial (during or within 30 days before SOFA)
* use of any supplemental n-3 fatty acid during the last 3 months
* intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire
* pregnant women and women of childbearing potential who do not use adequate contraception
* patients known to have a history of recent drug or alcohol abuse
D: Inclusion Criteria:

* Persistent atrial fibrillation

Exclusion Criteria:

* Contraindications or known hypersensitivity to n-3 PUFA
* Current treatment with n-3 PUFA for any reason
* Heart failure NYHA class IV
* Coronary artery bypass surgery or valve replacement within the past 3 months
* Planned cardiac procedures
* Known sick-sinus syndrome
* Diagnosis of Wolff-Parkinson-White
* Clinical significant valvular etiologies
* Presence of arrhythmia associated with an acute reversible condition
* Advanced chronic lung disease
* Contraindications for anticoagulation therapy
* Pregnancy or lactation
* Any non cardiac illness associated with a life expectancy of \< 2 years
* Treatment with any investigational agent within 3 month before randomization
* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol

Answer: C