Myocardial infarction Circulatory System Acute myocardial infarction
Conditions
Interventions
100,000 units of oral vitamin D or placebo at 0, 2 and 4 months. Total follow up is 6 months per patient.
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of myocardial infarction, based on the recently published Universal criteria for diagnosis of myocardial infarction: Troponin T greater than 0.02 plus one of the following: 1.1. Symptoms consistent with myocardial ischaemia 1.2. Electrocardiogram (ECG) changes consistent with myocardial ischaemia 1.3. New Q waves on ECG 1.4. New regional wall motion abnormality or evidence of new loss of viable myocardium on imaging 2. Admitted to Tayside Hospitals within 1 week of index event 3. Aged greater than 18 years, either sex 4. Minimum of 6 weeks after index event (to allow for medication stabilisation and percutaneous/surgical interventions)
Exclusion criteria
Exclusion criteria: 1. Estimated glomerular filtration rate (GFR) less than 40 ml/min (using the MDRD4 method) 2. Adjusted serum calcium less than 2.15 mmol/L or greater than 2.60 mmol/L 3. Liver function tests (LFTs) greater than 3 x upper limit of normal 4. Already taking vitamin D supplements. Consumption of fish oils will not be a contraindication to enrolment as the vitamin D content is very low relative to the dose used in the study. 5. Known metastatic malignancy 6. History of renal calculi or sarcoidosis 7. Supine systolic blood pressure (BP) less than 80 mmHg 8. Pregnant, lactating, or of childbearing age and not taking reliable contraception 9. Unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure (as of 21/02/2018): Change in endothelial function measured using the EndoPAT finger plethysmography system between baseline and 6 months Previous primary outcome measure: Change in endothelial function between baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures (as of 21/02/2018): 1. Change in blood pressure measured using OMRON HEP 705 oscillometric automated machine at 2 and 6 months 2. Change in endothelial function measured using the EndoPAT finger plethysmography system at 2 months 3. Changes in blood markers (tumour necrotising factor (TNF) alpha, brain natriuretic peptide (BNP), high sensitivity C-reactive protein (hsCRP), von Willebrand factor, E-selectin and thrombomodulin) measured using ELISA kits at 2 and 6 months 4. QT interval and dispersion measured using a 12 lead ECG at 2 and 6 months Previous secondary outcome measures: 1. Change in blood pressure at 2 and 6 months 2. Change in endothelial function at 2 months 3. Changes in tumour necrotising factor (TNF) alpha, brain natriuretic peptide (BNP), high sensitivity C-reactive protein (hsCRP), QT interval and dispersion, von Willebrand factor, E-selectin and thrombomodulin at 2 and 6 months | — |
Countries
United Kingdom
Outcome results
None listed