Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT02451293
Eligibility Criteria:
Inclusion Criteria:
1. Patients should be admitted to a coronary care unit for acute coronary syndrome (ACS), and should be enrolled within 4 weeks after the primary ACS.
2. Participants should be 18 years or older.
3. No sign of depression on Major Depression Inventory (MDI) at the point of enrolment.
4. Participants must sign an informed consent form
5. Females not in menopause (defined as no menstruation during the last 12 months) should have a negative pregnancy test.
Exclusion Criteria:
1. Known allergic reaction to melatonin.
2. Ongoing or previous pharmacological treated depression or bipolar disorder.
3. No dementia as determined by mini mental state examination score (MMSE) \< 24
4. At the point of inclusion no participation in another pharmacological intervention trial is allowed.
5. No diagnose of Rotor or Dubin-Johnson syndrome, epilepsy, sleep apnoea syndrome, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or multiple sclerosis is allowed.
6. Severe liver disease defined as transaminases above X 3 normal levels, and severe kidney disease defined as eGRF under 40 ml/min.
7. Ongoing hypnotic treatment.
8. Known sleep disorder (e.g. insomnia, restless legs etc.)
9. Work involving nightshifts.
10. Daily alcohol consumption above 5 units of alcohol (1 unit = 12 g alcohol)
11. Predictable poor compliance ( e.g. not speaking fluent Danish)
12. Pregnant or breastfeeding.
13. Severe, life-threatening medical condition, that implies that the patient cannot participate in a the study course. (e.g. cancer, stroke, )
14. Indication for coronary artery bypass graft (CABG).
For the MEFACS subtrial - (single center)
15. Conditions that preclude/make impossible the measurement of reliable RHI (e.g. patient with only one arm, known side-difference in brachial arterial blood pressure and other factors).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02451293
Study Brief:
Protocol Section:
NCT02451293