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The effect of acetaminophen on ischemia- reperfusion injery in patients with ST segment elevation acute myocardial infarction treated by primary percutaneous coronary intervention

Protocol summary

Summary
The aim of the current study was to determine the effect of acetaminophen on ischemia- reperfusion injery in patients with ST segment elevation acute myocardial infarction(STEMI) treated by primary percutaneous coronary intervention (pPCI). This study is a double blind randomized clinical trial which its population is all of the patients with STEMI diagnosis. Inclusion criteria include: patient willingness to take part in the study, informed consent, age above 20 and below 65 years and include all patients with STEMI. Exclusion criteria included a history of kidney and liver disease, acute hepatitis, asthma, pregnancy, cardiac output less than 30%, history of heart failure, and consumption of acetaminophen, warfarin, salicylates, barbiturates, carbamazepine, hydantoin and rifampin, rifabutin, isoniazid, alcohol, and antioxidants drugs. A total of 60 patients will be selected among those eligible. Patients were randomly divided in two groups. Before the angioplasty case group receive 1 grams of paracetamol, and then patient hemodynamic parameters and blood biomarker will be checked before and 6 hours after p PCI. Also in order to measure the amount of cellular damage, blood sample will be taken from the coronary of heart before and after p PCI, and in order to evaluate the levels of homocysteine, glutathione and malondialdehyde serum of blood will be kept at -20 C.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011828454N3
Registration date: 2017-02-11, 1395/11/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Atefeh Asadmobini
Name of organization / entity
Kermanshah University of Medical Science, Cardiovascular Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 83 3839 5970
Email address
aasadmobini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Scince
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acetaminophen on ischemia- reperfusion injery in patients with ST segment elevation acute myocardial infarction treated by primary percutaneous coronary intervention
Public title
The effect of acetaminophen on ischemia- reperfusion injery in patients with ST segment elevation acute myocardial infarction treated by primary percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: patient willingness to take part in the study, informed consent, age above 20 and below 65 years and include all patients with STEMI. Exclusion criteria included a history of kidney and liver disease, acute hepatitis, asthma, pregnancy, cardiac output less than 30%, history of heart failure, and consumption of acetaminophen, warfarin, salicylates, barbiturates, carbamazepine, hydantoin and rifampin, rifabutin, isoniazid, alcohol, and antioxidants drugs.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of medical Sciences
Street address
Vice Chancellor for Research and Technology- Building No. 2- Kermanshah University of medical Sciences-
City
Kermanshah
Postal code
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
561

Health conditions studied

1

Description of health condition studied
ST segment elevation acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
homocysteine
Timepoint
Before and after primaryprecutanous coronary intervention
Method of measurement
Measuring the level of homocysteine in coronary blood sample

2

Description
Glutathione
Timepoint
Before and after primaryprecutanous coronary intervention
Method of measurement
Measuring the level of Glutathionein coronary blood sample

3

Description
Malondialdehyde
Timepoint
Before and after primaryprecutanous coronary intervention
Method of measurement
Measuring the level of malondialdehydecoronary blood sample

Secondary outcomes

1

Description
LDH
Timepoint
Before and six hours after primary precutaneous coronary intervention
Method of measurement
Measuring the level of LDH from peripheral blood serum

2

Description
Troponine
Timepoint
Before and six hours after primary precutaneous coronary intervention
Method of measurement
Measuring the level of troponinefrom peripheral blood serum

3

Description
CPK-mb
Timepoint
Before and six hours after primary precutaneous coronary intervention
Method of measurement
Measuring the level of CPK-mb from peripheral blood serum

4

Description
CPK
Timepoint
Before and six hours after primary precutaneous coronary intervention
Method of measurement
Measuring the level of CPK from peripheral blood serum

Intervention groups

1

Description
Case group receive 1 gram paracetamol before primary percutaneous coronary intervention
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
Vice Chancellor for Research and Technology of Kermanshah University of Medical Sciences- Building No. 2 - shheed Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Kermanshah 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
Kermanshah University of medical Science
Full name of responsible person
Atefeh Asadmobini
Position
Master science/Researcher
Other areas of specialty/work
Street address
Cardiovascular research center-Imam Ali Hospital- Shaheed beheshti Blv.
City
Kermanshah
Postal code
Phone
+98 83 3839 5970
Fax
Email
a.asadmobini@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah Univercity of Medical Science
Full name of responsible person
Dr Sareh Mohammadi
Position
Cardiologist
Other areas of specialty/work
Street address
Imam Ali Hospital
City
Kermanshah
Postal code
Phone
+98 83 3839 5970
Fax
Email
sarehonline@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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