Evaluation the effects of N Acetyl Cysteine (NAC) in myocardial reperfusion of patients with STEMI undergoing to P-PCI in Karaj's Shahid Rajayi hospital in 2020
The effects of N Acetyl Cysteine in myocardial reperfusion of patients with STEMI undergoing P-PCI will be evaluated to reduce slow flow in angiography.
Design
Two arms parallel-group double-blinded randomized trial with a control group, phase 3 on 142 patients. Rand function on excel software for block randomization was used.
Settings and conduct
Catheterization Laboratory Angiography Operation Room in Shahid Rajaii Hospital
Participants/Inclusion and exclusion criteria
Patients with STEMI candidate for primary PCI who not having renal failure, allergy to N Acetyl Cysteine, and asthma included.
Intervention groups
1200mg N Acetyl Cysteine before primary PCI and every 12 hours for 2 days will be injected intravenously for the intervention group. For the control group serum dextrose 5% as a placebo will be used.
Main outcome variables
Troponin I; CK-MB; TIMI Flow Grade; Corrected TIMI Frame Count; Left Ventricle Ejection Fraction; Left Ventricle End Diastolic Volume; Left Ventricle End Systolic Volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200519047506N1
Registration date:2020-09-18, 1399/06/28
Registration timing:registered_while_recruiting
Last update:2020-09-18, 1399/06/28
Update count:0
Registration date
2020-09-18, 1399/06/28
Registrant information
Name
Huma Arabi
Name of organization / entity
Alborz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 0486
Email address
miss.arabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of N Acetyl Cysteine (NAC) in myocardial reperfusion of patients with STEMI undergoing to P-PCI in Karaj's Shahid Rajayi hospital in 2020
Public title
Evaluation the effect of N Acetyl Cystein (NAC) in myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted at Shahid Rajaii hospital in karaj in 2020
Patients admitted with myocardial infarction
Patients who had STEMI
Patients candidate for Primary PCI
Exclusion criteria:
Patients who have renal failure
Patients who have allergy to N Acetyl Cystein
Patients who have asthma
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with a block size of 4 patients which every single block contains the equal groups. There was 6 possible way for randomization in a block. We randomly choose blocks, so the total on A and the total on B only differed by a maximum of 2. So say the first Block is AABB and the total subjects on A and B will be; (1,0), (2,0), (2,1), (2,2)
Blinding (investigator's opinion)
Double blinded
Blinding description
Interventionist and the researcher who analyzes data both use patient's code. Also, title groups were coded with A and B whom none of them know which one is the NAC or control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Science