Please select the eligibility criteria that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Inclusion Criteria:

* Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
* Ability to take Ω-3-FAE or olive oil without risk
* Informed consent

Exclusion Criteria:

* Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
* Known hypersensitivity to study medication
* Dislike of fish oil
* Haemorrhagic diathesis
* Unwillingness to discontinue other medications containing fish oil
* Legal incapacity
* History of drug or alcohol abuse within 6 months
* Any investigational therapy within one month of signing informed consent form
B: Inclusion Criteria:

* Male or female
* 50 years of age or older
* Residing in the community at baseline (includes assisted living facilities, but excludes long-term care nursing facilities)
* MMSE (Mini-Mental State Examination) at screen of 14-26 (inclusive)
* No medical contraindications to study participation
* Fluent in English or Spanish
* Corrected vision and hearing sufficient for compliance with testing procedures
* Supervision available for study medication
* Caregiver/study partner to accompany participant to all visits
* Study partner must have direct contact with the participant more than 2 days/week
* Able to ingest oral medication
* Daily DHA consumption less than or equal to 200 mg/day in prior two months estimated by an abbreviated DHA food frequency questionnaire
* Neuroimaging consistent with the diagnosis of AD at some time after the onset of the memory decline
* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the investigator
* Stable use of cholinesterase inhibitors and memantine is permitted if doses are stable for 4 months prior to enrollment

Exclusion Criteria:

* Non-AD dementia
* Residence in a long-term care facility at baseline
* History of clinically significant stroke
* Modified Hachinski Ischemia score ≥ 4
* Current evidence or history in past two years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Sensory impairment which would prevent subject from participating in or cooperating with the protocol
* Use of another investigational agent within two months
* Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular (including history of ventricular fibrillation or ventricular tachycardia), pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
* Active neoplastic disease (skin tumors other than melanoma may be included; participants with stable prostate cancer may be included at the discretion of the Project Director)
C: Inclusion Criteria:

* All non- exudative forms of age related maculopathy

Exclusion Criteria:

* Exudative age related maculopathy
D: Inclusion criteria:

* Men and women
* Aged 60 through 80 y
* Verified clinically diagnosed myocardial infarction up to 10 y before randomization
* Written informed consent

Exclusion criteria:

* Living in a nursing home or other institution
* Participation in another scientific study
* Habitual margarine intake \< 10 g per day
* Habitual fish intake \> 150 g per day
* Habitual alcohol intake \> 6 drinks per day
* Use of fish oil capsules or other supplements containing omega-3 fatty acids
* Presence of cancer with \< 1 y of life expectancy
* Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21)
* Unintended weight loss \> 5 kg in the past year
* Lack of facilities for cooled margarine storage at home
* Inability or unwillingness to comply with study procedures

Answer: A