the effect of early ambulation on oxidative stress index in patients undergoing coronary angiography
Design
This study is a type of clinical trial in Shiraz. participants of this study fall into two groups: intervention and control (25 people per group).
Settings and conduct
This study is a type of clinical trial in which 50 patients with angiographic candidate referred to Al-Zahra Heart Hospital in Shiraz will be selected based on the conditions of admission to the study And after obtaining written consent to participate in the study In the form of block crashes, they will fall into two groups: intervention and control (25 people per group). The control group receives routine care in the CCU and post- angiography, In this way, during the whole study hours (6 consecutive hours) they will be lying on their backs, along with the flatness of the head and the flatness of the foot under angiography. The 4kg sandbag will be placed on the catheter entry for 6 hours. In the intervention group, the laying time of the sandbag is reduced from 6 hours to 4 hours, and patients are allowed to move around the bed in a limited way by changing the one-hour position to lying on their backs, right side and left side .
Participants/Inclusion and exclusion criteria
Age below 75 years
Conscious satisfaction and willingness to participate in the study
Having no back pain
angiography for the first time
trans femoral coronary angiography
Intervention groups
In the intervention group, the laying time of the sandbag is reduced from 6 hours to 4 hours.
Main outcome variables
Oxidative stress in blood.This index is measured by using blood samples of participating patients and malondialdehyde test with a special kit as an indicator of oxidative stress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041101N2
Registration date:2020-11-24, 1399/09/04
Registration timing:prospective
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Majid Najafi Kalyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4251
Email address
najafikalyani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of early ambulation on oxidative stress index in patients undergoing coronary angiography
Public title
the effect of early ambulation on oxidative stress index in patients undergoing coronary angiography
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age below 75 years
Conscious satisfaction and willingness to participate in the study
Having no back pain
angiography for the first time
trans femoral coronary angiography
Exclusion criteria:
People who simultaneously with coronary angiography balloon is also done
Lack of cooperation and participation in the study
Having underlying disease (including lumbar disc surgery, low back pain, autoimmune disease, cancer)
Complications during angiography
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of this study are assigned to two A, B groups based on the random block method using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical nurse and laboratory technician are not aware of assignment to the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.SUMS.REC.1399.788
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Malondialdehyde as an indicator of oxidative stress in the blood
Timepoint
Before and 6 hours after coronary angiography
Method of measurement
Take a patient blood sample and check with a malondialdehyde kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives the same routine care, but the sanding time is reduced to 4 hours instead of 6 hours, and patients are allowed limited movement in bed by changing the position for one hour to lying on their back, right side and left side. . Immediately before angiography and 6 hours after it is performed by the researcher, 5 cc of venous blood is taken from each patient to measure oxidative stress index (malondialdehyde), and it is poured into a chelate tube and then transferred to the laboratory where serum is isolated. And stored at -70 ° C until testing.
Category
Diagnosis
2
Description
Control group: The control group received routine care after angiography, including placing a sandbag for 6 hours and absolute rest for 24 hours, immediately before angiography and 6 hours after it was performed by the researcher from each patient with 5 cc of intravenous blood to measure the stress index. The oxidant (malondialdehyde) is taken and poured into a chelate tube and then transferred to a laboratory where the serum is separated and stored at -70 ° C until the test is performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Heart Hospital
Full name of responsible person
Dr. Peyman Izadpanah
Street address
Sibooyeh St. Astaneh, Alzahra heart hospital
City
Shiraz
Province
Fars
Postal code
7164954937
Phone
+98 71 3739 8811
Email
hfcmanager@sums.ac.ir
Web page address
https://hfhc.sums.ac.ir/?sub=51
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Shamsodini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Email
Shamssara2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4251
Fax
Email
najafikalyani@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4251
Fax
Email
najafikalyani@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Analyzed data can be shared after completion of the study as an article.
When the data will become available and for how long
Start of access period 6 months after publication of results.
To whom data/document is available
All of the researchers in Medical Sciences Universities.
Under which criteria data/document could be used
Analysis of data based on statistical software.
From where data/document is obtainable
Dr. Majid Najafi Kalyani
What processes are involved for a request to access data/document
Sending request, permission from Ethic Committee, sending data