Low serum level of vitamin D is accompanied by major cardiovascular diseases that documented in several studies. Vitamin D level in serum is low in major cardiovascular diseases such as Acute ST elevation Myocardial Infarction. In this study we will try to examine the effect of vitamin D in reduction of LV remodeling in Acute ST Elevation Myocardial Infarction. We include patients with acute Myocardial Infarction after obtaining informs consent. Patients will be randomized in two groups of placebo and vitamin D. Those with any history of vitamin D intoxication or parathyroid disease were excluded. We test Vitamine D level and Matrix Methaloproteinase 9 in two sessions, at admission and 1 month later. Vitamin D 300,000 IU is administered upon admission after taking blood sample. We evaluate the effect of Vitamine D on Left ventricular Remodeling by measuring MMP-9 and echocardiographic data at baseline and after one month. LV end diastolic volume was the major echocardiographic data used for comparison.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212288698N6
Registration date:2014-06-26, 1393/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin D in prevention of LV remodeling in Patients with STEMI that undergo Primary PCI
Public title
Effect of Vitamin D in prevention of Cardiac Remodeling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria
-Patient with STEMI who are candidates for Primary PCI(Arrived at the hospital withine 12 hours of chest pain)
-Patient's satisfaction
Exclusion Criteria
-History of Vitamin D intoxication
-Known parathyroid disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Tehran Heart Center, Kargar Shomali Ave
City
Tehran
Postal code
Approval date
2012-08-16, 1391/05/26
Ethics committee reference number
319رم ت
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
121
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
left ventricular(LV) remodeling
Timepoint
STAT and after one month
Method of measurement
Serum Level of MMP9 by ELISA
Secondary outcomes
1
Description
Serum Level Of Vitamin D
Timepoint
stat and 1 month later
Method of measurement
Serum Level by ELISA
Intervention groups
1
Description
IM injection of Vitamin D 300000 IU
Category
Treatment - Drugs
2
Description
Placebo of Vitamin D IM injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Street address
Jalale Ale Ahmad Cross St., North Kargar St., Tehran Heart Center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
somayyeh kalaiy
Street address
Tehran Heart Center, U2 Floor, Research Ward, Kargar shomali Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Mohammad Hasan Akhbarieh
Position
Cardiology Resident
Other areas of specialty/work
Street address
U2 Floor, Research Ward, North Kargar St., Tehran Heart Center
City
Tehran
Postal code
Phone
+98 21 8802 9245
Fax
Email
ekhbarieh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Haj Hossein Talasaz
Position
Assistant Professor
Other areas of specialty/work
Street address
U2 Floor, Research Ward, North Kargar St., Tehran Heart Center
City
Tehran
Postal code
Phone
+98 21 8802 9650
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mohammad Hasan Akhbarieh
Position
Other areas of specialty/work
Street address
Jalale Ale Ahmad Corss St., North Kargar St., Tehran Heart Center
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)