We designed this study to evaluate the effect of N-acetylcystein on biomarkers of coronary reperfusion and Troponin I as well as high sensitive C-Reactive Protein (hs-CRP) in patients undergoing percutaneous coronary intervention. Double blind randomized clinical trial on 100 patients in 2 groups (intervention & control) are selected. Patients with St-segment elevated myocardial infarction included. Patients were excluded if had: emergency for cardiac bypass ,cardiogenic shock or underwent rescue percutaneous coronary intervention . The patients in Intervention group were adminitered to take 100 mg/kg IV bolus N-acetylcystein and then intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention and patients in control group received standard regimens. Primary outcomes were Troponin I and hs-CRP measured before and 48 hours after percutaneous coronary intervention. Patients were assessed for coronary blood flow after percutaneous coronary intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301048698N8
Registration date:2013-01-19, 1391/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-19, 1391/10/30
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 Heart Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evluation of N-acetyl cystein on myocardial perfusion and plasma troponin I and hsCPR levels in patients undergoing primary PCI
Public title
NAC effects on patients with AMI undergoing angioplasty
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; treatment with glycoprotein IIb/IIIa inhibitors during PCI ; sensitivity to sulfonamides ; Major surjery; Unsatisfactory to enter to study
Age
From 18 years old to 90 years old
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Jalal Ale Ahmad, North Karegar
City
Tehran
Postal code
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
586
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
Troponin I
Timepoint
Baseline and after 48 hours
Method of measurement
Elisa Kit
2
Description
hs-CRP
Timepoint
Baseline and after 48 hours
Method of measurement
Elisa Kit
3
Description
Myocardial Perfusion
Timepoint
Baseline and after Primary Percutaneous Coronary Intervention
Method of measurement
Myocardial Blush Grage and TIMI flow
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: The patients in Intervention group were adminitered to take 100 mg/kg IV bolus N-acetylcystein and then intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention
Category
Prevention
2
Description
Control: Received Standard treatment as for patients with acute myocardial infarction
Category
Other
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 Heart Center, Tehran University of Medical Sciences
Full name of responsible person
Somayeh Kalaiee
Street address
North Kargar St., Jalale Ale Ahmad St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center, 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 Heart Center, Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz, Mostafa Bahremand
Position
Assistant Professor, Fellowship of Interventional Cardiology
Other areas of specialty/work
Street address
North Kargar St., Jalale Ale Ahmad
City
Tehran
Postal code
Phone
+98 218802960050
Fax
Email
atalasaz@razi.tums.ac.ir, mosaffa52@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Full name of responsible person
Younes Nozari, Azita Hajhossein Talasaz
Position
Associate Professor, Assistant Professor
Other areas of specialty/work
Street address
North Kargar St., Jalale Ale Ahmad St
City
Tehran
Postal code
Phone
+98 218802960050
Fax
Email
y_nozari@yahoo.com, 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
16 Azar St, 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
Sharing plan
Deidentified Individual Participant Data Set (IPD)