The main objective of this study was to evaluate the efficacy of N-acetylcysteine in the prevention of cardiac remodeling secondary to ischemia and acute myocardial infarction. Hundred patients with diagnosis of acute myocardial infarction were assigned into two groups (50 each) to receive NAC 600 mg BD or placebo with the same dose for 3 days. The early biomarkers of remodeling will be measured after 24 and 72 hours. The results will be compared in these two groups to assess the possible effects of NAC on early cardiac remodeling biomarker.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905093449N2
Registration date:2010-09-04, 1389/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-04, 1389/06/13
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of N-acetyl cysteine on the Early Remodeling Biomarkers (MMPs & NT-Pro-BNP) in patients following acute myocardial infarction
Public title
Evaluation of N-acetylcystein effects on cardiac remodeling biomarkers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ST-elevation AMI diagnosed by the following criteria: (1) typical chest pain lasting >30 minutes, (2) 1-mm ST elevation in 2 contiguous limb leads or 2-mm ST elevation in 2 contiguous chest leads, and (3) increase in creatine kinase or in troponin T level to 2 times the upper limit of normal. Exclusion criteria: previous AMI or HF, AF or valve disease, and history of neoplastic, renal, liver, or thyroid disease, acute or chronic infections or autoimmune diseases, under treatment with anti-inflammatory drugs, or underwent surgical procedures in the preceding 3 months, unwillingness for entering in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
89-01-33-10373
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
MMP-9 as early cardiac remodeling biomarker
Timepoint
24 and 72 hours after administration of NAC
Method of measurement
Elisa
2
Description
Nt-pro-BNP as early cardiac remodeling biomarker
Timepoint
24 and 72 hours after administration of NAC
Method of measurement
Elisa
3
Description
MMP-2 as early cardiac remodeling biomarker
Timepoint
24 and 72 hours after administration of NAC
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: NAC 600 mg BD PO for 3 days
Category
Prevention
2
Description
Control: Placebo BD PO for 3 days
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Mojtaba Salarifar
Street address
Tehran Heart Center, North Karegar Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Fatemeh Saeedi
Street address
Tehran University of Medical Sciences, Enghelab 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 sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enghelab Ave,
City
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Fax
+98 66954709
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)