Effect of primary angioplasty with and without remote ischemic postconditioning in a patient's hand on the level of oxidative stress in patients with acute myocardial infarction
The study included 82 patients with a first acute myocardial infarction who have come to the emergency department and are candidate for primary angioplasty. Patients are allocated into two groups (intervention and control group) based on the Randomization.org. Patients with 20- 80 years old and with first myocardial infarction who have come in the first 12 hours after onset of symptoms, in the absence of contraindication of thrombolytic therapy are candidates to be studied. Patients with left bundle branch block, pacemakers, cardiogenic shock, are excluded. In both groups three cycles of inflation and deflation of cuff, each one for 5 minutes, will be intermittent implemented. According this protocol, in the study group the cuff will be inflated to 30 mmHg upper than systolic pressure for 5 min and then for 5 min deflation. In the control group pressure inflation will be done to 30 mmHg lower than diastolic pressure. Blood samples for assessment of oxidative stress factors, 10 min and 1 hour after the start of the protocol was prepared and Extracted serum from that samples stored at -70 freezer. To evaluate the level of oxidative stress, SOD, GPX, and TAC will be measured. Oxidative stress level compared the two groups together. The purpose of this study is using this protocol as a post-conditioning factor during primary angioplasty in acute myocardial infarction patients to reduce or avoid increasing the size of the infarct.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101416229N4
Registration date:2015-05-10, 1394/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Samad Ghaffari
Name of organization / entity
Cardiovascular Research Center, Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3576
Email address
ghafaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-05-01, 1394/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of primary angioplasty with and without remote ischemic postconditioning in a patient's hand on the level of oxidative stress in patients with acute myocardial infarction
Public title
Remote ischemic postconditioning in Acute myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age between 20-80 years
2) Patients with a first MI in the first 12 hours after symptoms have gone.
3) Patients who have not received thrombolysis
4) Don't having severe disease
5) Not having the use of drugs cytotoxic and radiation
6) No blood transfusion in the last month
7) Willingness to participate in the study
8) patients with BMI = 26 ± 5
Exclusion criteria:
1) Receiving other treatment, such as the thrombolytic therapy or emergency bypass
2) Patients with LBBB
3) People who have heart pacemakers
4) Patients with cardiogenic shock
5) Patients who received DC shock
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients in the study, will be unaware of patients' access to grouping. The person responsible for data analysis and laboratory analyzers will be unaware of patients' access to grouping.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences- university street
City
Tabriz
Postal code
Approval date
2014-10-09, 1393/07/17
Ethics committee reference number
93110
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21.0, I21
ICD-10 code description
Acute transmural myocardial infarction of anterior wall, Acute transmural myocardial infarction of inferior wall, Acute transmural myocardial infarction of other sites
Primary outcomes
1
Description
Oxidative Stress
Timepoint
Blood samples were collected at the opening of the vessel and then 60 minutes after the start of the procedure
Method of measurement
Spectrophotometry using specific kits
Secondary outcomes
1
Description
ST Resolution
Timepoint
Electrocadiography before intervention and 90 minute after then
Method of measurement
Electrocadiography
Intervention groups
1
Description
In the control group, the cuff pumped for 5 minutes to 30 mmHg under diastolic pressure of patient and then opens for 5 minutes. This procedure is performed three times for 5 minutes.
Category
Prevention
2
Description
In the test group cuff pumped for 5 minutes to 30 mmHg above systolic pressure of patient and then opens for 5 minutes. This procedure is performed three times for 5 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Hassan Ali Lotfollahi
Street address
Cat. Lab - Shahid Madani Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cardiovascular Research Center of Tabriz University of Medical Sciences
Full name of responsible person
Samad Ghafari
Street address
university st. Imam Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cardiovascular Research Center of Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Vice chancellor for research- Tabriz University of Medical Sciences
City
Tabriz
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, Tabriz University of Medical Sciences
Proportion provided by this source
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
Shahid Madani Hospital
Full name of responsible person
Samad Ghafari
Position
Professor of Cardiology
Other areas of specialty/work
Street address
Shahid Madani Hospital - University st.
City
Tabriz
Postal code
Phone
+98 41 3335 7767
Fax
Email
ghafaris@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mustafa Mohammadi
Position
Professor of Physiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
۵۱۶۶۵۱۱۸
Phone
+98 41 3335 7767
Fax
Email
Mustafa Mohammadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Ali Lotfollahi
Position
Master Science
Other areas of specialty/work
Street address
Shahid Madani Hospital
City
Tabriz
Postal code
5147976851
Phone
+98 41 3230 9178
Fax
Email
hh10ll@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)