The main objective of this study was to determine the mechamism of N-acetylcysteine in the prevention of cardiac remodeling secondary to ischemia and acute myocardial infarction. In 80 patients with diagnosis of acute myocardial infarction who were assigned into two groups (40 each) to receive NAC 600 mg BD or placebo with the same dose for 3 days, the level of tumor necrosis factor-alpha and transforming growth factor-beta will be measured after 24 and 72 hours. The results will be compared in these two groups to determine if oxidative stress plays a role in NAC effect on the prevention of early cardiac remodeling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102283449N5
Registration date:2011-08-01, 1390/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-01, 1390/05/10
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
2010-08-01, 1389/05/10
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the mechanism of N-acetylcysteine in the prevention of early remodeling, role of oxidative stress
Public title
Determining NAC mechanism in the prevention of early remodeling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria; Patients with criteria of first episode of ST-elevation AMI including typical chest pain with the duration of more than 30 minutes, >1-mm ST elevation in ≥2 adjacent limb leads or >2-mm ST elevation in ≥2 adjacent chest leads, and a raise in creatine kinase or in troponin T level 2 times the upper limit of normal were included in the study.
Exclusion Criteria; Patients with history of prior AMI, heart failure, atrial fibrillation, valvular dysfunction, and neoplastic, renal, liver, or thyroid diseases were excluded from the study. Moreover patients with current acute or chronic infections, autoimmune diseases, surgical procedures in the past 3 months; under treatment with anti-inflammatory drugs, supplements and antioxidants, subsequent MI, discharge or death during the study period were excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tehtan University of Medical Sciences, Enghelab Ave
City
Tehran
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
90-2-33-13830
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
Tumor necrosis factor-alpha
Timepoint
24 and 72 hours after administration of NAC or Placebo
Method of measurement
Elisa
2
Description
Transforming growth factor-beta
Timepoint
24 and 72 hours after administration of NAC or Placebo
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: NAC 600 mg BD for 3 days per oral
Category
Prevention
2
Description
Control: Placebo BD for 3 days per oral
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saieedi
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
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)