Acute myocardial infarction with ST segment elevation anterior
Conditions
Interventions
Product Name: Calcifediol
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CALCIFEDIOL
CAS Number: 63283-36-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
INSTITUTO DE INVESTIGACION SANITARIA FJD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 40 and 85 years. 2. Be ready to be discharged after STEMI previous location which is complete revascularization and defined as suggestive symptoms such as chest tightness, in the arms or jaw, or simply supported as sweating, nausea, vomiting and malaise bad defined longer than 20 minutes with ST-segment elevation in the ECG of 0.2 mV in ?2 contiguous precordial leads unresponsive to nitroglycerin followed Troponin I> 0.12 with a standard curve. 3. Acceptance and signing the consent for the study after receiving adequate information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: 11. Death during the index event 2. Age younger than 40 or older than 85 years 3. Complications prolong their stay more than 7 days in the index event. 4. Infarct-s-s prior infarction. 5. Disease limiting survival 6. Systemic inflammatory disease or autoimmune 7. concomitant restrictive cardiomyopathy, dilated or hypertrophic. 8. severe ventricular hypertrophy of any etiology defined as ?17 mm wall thickness ?16 mm in men and women 9. renal glomerular filtration lower estimate of 45 ml / min / 1.73 m2 by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) 10. The need for heart transplantation 11. ejection fraction less than 30% 12. Failure to perform the desirable revascularization 13. Revascularization pending at the time of discharge 14. valvular prosthesis 15. Aortic stenosis with average gradient> 25 mm Hg (Doppler) and any other valve stenosis. 16. moderate or severe valvular insufficiency at any level 17. Hypersensitivity or intolerance vitamin D supplement to employ or to any of the excipients. 18. Indication of treatment with vitamin D and / or calcium supplements or patient decision making these compounds in the absence of clinical indication. 19. Concomitant therapy with drugs that could interfere with calcifediol pK-pD. 20. Concomitant diseases that could interfere with calcifediol pK-pD serum 21. Calcium> 10.5 mg / dl, history of hypercalciuria or calcium stones 22. Contraindications to MRI: Claustrophobia, pacemaker, defibrillator and / or resynchronization, or are anticipated to need during the study. 23. Inability to follow. 24. Difficulty to meet the study treatment as determined by your doctor 25. Patient refusal to participate and signed informed consent. 26. Pregnancy or breast-feeding state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of vitamin D3 on ventricular remodeling in patients with anterior STEMI.;Secondary Objective: A. Assess the effect of vitamin D on systolic and diastolic function in patients with anterior STEMI. B. Study in patients with anterior STEMI, the effect of vitamin D on: ? -The endothelial function (only in University Hospital FJD). ? -Levels of prognostic biomarkers: C-reactive protein high sensitivity (hsCRP), N-terminal pro-peptide (NT-proBNP), galectin-3, MCP-1 (monocyte chemoattractant protein-1) and brain natriuretic lipids. ? -The calcidiol levels, FGF-23, klotho, PTH and P in blood. C. Analyze whether there are differences in the above objectives among patients with plasma levels of FGF-23 and Klotho levels above and below the median, and in subgroups of patients with levels of calcidiol (metabolite of vitamin D) ?15 , 00 ng / ml, from 15.01 to 30.00 ng / mL, from 30.01 to 55.00 ng / ml and> 55.00 ng / ml. D. To evaluate the safety and tolerability of the preparation.;Primary end point(s): Necrosis-fibrosis and myocardial remodeling in Cardiac Magnetic Resonance after a year of treatment, measured as: ? ejection fraction, assessed as a percentage of diastolic intraventricular blood volume ejected in systole (100x [volume diastolic-systolic volume] / diastolic volume) ? Left ventricular end-diastolic volume ? Left ventricular end-systolic volume ? Myocardial risk, defined as the area of edema. ? size of the infarcted area, defined as LGE (STIR signs of high intensity). ? salvaged myocardium, defined as the difference between the myocardium at risk and infarct zone. The last three variables are measured as a percentage of the volume of total left ventricular myocardium. In addition, the necrotic myocardium be expressed in grams. All results are given in absolute numbers and corrected for body surface area.;Timepoint(s) of evaluation of this end point: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: one year;Secondary end point(s): Data Echocardiography ventricular diameters and thicknesses, changes in contractility, ejection fraction (assessed as a percentage of intraventricular blood-diastolic volume that is ejected him systole (100 x [volume diastolic-systolic volume] / diastolic volume), time deceleration peaks E and A waves, E / A ratio, isovolumic relaxation time (pulsed Doppler) waves E 'and A' (tissue Doppler). ? Serum calcidiol, FGF-23, and P in plasma PTH to see the effect of vitamin D supplementation on mineral metabolism. ? Serum NT-proBNP, MCP-1, galectin-3 and hsCRP. ? Lipid Levels: Total cholesterol, LDL, HDL, triglycerides and non-HDL cholesterol. ? Endothelial Function: Degree of flow-mediated vasodilation. Adverse events % and description % Treatment Compliance | — |
Countries
Spain
Contacts
Public ContactLucía Llanos Jimenez
Unidad de Investigación Clínica
Outcome results
None listed