Evaluating the effect of N-acetyl cysteine on the Late Remodeling’s Biomarkers and ecocargdiography parameters in patients following acute myocardial infarction
The aim of this study was to evaluate the effect of N-acetylcystein on late remodeling biomarkers and echocardiographic findings in patients following acute myocardial infarction. This would be a prospective clinical trial conducted on 50 patients of both sexes with the diagnosis of STEMI. Those patients who became candidate of primary PCI will be included in this study. Therefore, all patients received thrombolytics would be excluded. One group of patients will be considered as control group and in the other group NAC with the dose of 100 mg/kg and then 10 mg/kg/hr for 12 hours will be administered. Remodeling biomarker (MMP-9) was measured at the arrival time and after a month. Echocardiographic evaluations will be conducted upon arrival and within a month. These findings will be compared between these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211168698N3
Registration date:2012-12-14, 1391/09/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-14, 1391/09/24
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
2012-12-01, 1391/09/11
Expected recruitment end date
2013-11-01, 1392/08/10
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 Late Remodeling’s Biomarkers and ecocargdiography parameters in patients following acute myocardial infarction
Public title
NAC effect on late remodeling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Myocardial infarction patients who were candidate of primary PCI . Exclusion Criteria:rescue pci; emergency for cardiac bypass ; cardiogenic shock; life expactancy less than 6 months; Age less than 18 years old; Uncontrolled hypertension; Thrombocytopenia; Malformation or aneurysm; sever chronic renal failure; Sever liver failure; sensitivity to sulfonamides ; Major surgery; Unsatisfactory to enter to 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)
Triple 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
2012-11-14, 1391/08/24
Ethics committee reference number
19189
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
Echocardiography findings of remodeling (LVEDV)
Timepoint
Baseline and after a month
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Level of MMP-9
Timepoint
Baseline and after a month
Method of measurement
Serum level-Elisa kit
Intervention groups
1
Description
Intervention: Bolus dose of NAC 100 mg/kg then 10 mg/kg/hr for 12 hours- During the intervention NAC will be administered intracoronary
Category
Treatment - Drugs
2
Description
Control group: Receive D5W in the same volume as NAC
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Azita Hajhossein Talasaz
Street address
North Kargar St., Jalal Al Ahmand St.
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
Research Deputy, Tehran University of Medical Sciences, Qods St., Keshavarz Blv.
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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Assistant Professor, Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Assistant Professor, Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.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
Assistant Professor, Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
#9 East Babak, Farid Afshar St., Dastgerdi St.
City
Tehran
Postal code
Phone
+98 21 2227 4767
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)