Clinical trial to evaluate the efficacy of vitamin D on ventricular remodeling in patients with acute myocardial infarctio

• Conditions: Acute myocardial infarction with ST segment elevation anterior; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004512-11-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACION SANITARIA FJD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified