The effect of activation and implementation of the Code STEMI on "Door to balloon time" in patients with myocardial infarction with ST-segment elevation
Determine the effect of setting up the STEMI code on ;Door-to-balloon time;
in Patients with ST stroke who referred to Booali Sina Hospital in Qazvin
Design
Semi-experimental study with control and intervention group, with available sampling, sample size equal to 50
Settings and conduct
This study will be carried out on patients who are referred to the hospital of Boali Sina Qazvin by EMS for signs of an acute myocardial infarction.
Participants/Inclusion and exclusion criteria
Entry requirements:
All patients with acute and Typical heart disease referred by the EMS to a selected treatment center affiliated with Qazvin University of Medical Sciences and confirmed by the cardiologist to diagnose acute STEMI.
Conditions of failure to enter:
Referral of the patient to the hospital after more than 12 hours from the onset of pain.
Referral of patient from other treatment centers.
Patients hospitalized in other parts of the hospital who have had a new heart attack.
Not satisfying the patient for primary angioplasty.
Intervention groups
The study has two groups of control and intervention.
In the control group, the ; Door-to-balloon time; time, is measured and recorded without making any changes in the hospital's common practice in transferring these patients to the cath lab.
In the intervention group, after entering these patients into the hospital, a team called "STEMI Code", consisting of an emergency medicine specialist, a cardiologist, two nurses and two crew, will be called up with specific job descriptions and the patient's condition will be required Perform angioplasty, and if confirmed, the patient is immediately transmitted to the Cath lab.; Door-to-balloon time; Time , is also measured and recorded for this group and finally compared with the control group.
Main outcome variables
Chenge in ; door to balloon time;
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20171210037814N1
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Fateme Jalalian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 6428
Email address
f54.jalalian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of activation and implementation of the Code STEMI on "Door to balloon time" in patients with myocardial infarction with ST-segment elevation
Public title
Effect of Code STEMI on "Door to balloon time"
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with acute and typical heart disease referred to the emergency department of the selected treatment center affiliated with Qazvin University of Medical Sciences.
Patients should be referred by EMS.
The diagnosis of acute STEMI in patients should be confirmed by a cardiologist.
Exclusion criteria:
Referral of the patient to the hospital after more than 12 hours from the onset of pain.
Referral of patient from other treatment centers.
Patients hospitalized in other parts of the hospital who have had a new heart attack.
Not satisfying the patient for primary angioplasty.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study has two groups of patients with acute myocardial infarction, which, according to the time of referral to the hospital (before or after the start of the STEMI code), fall into one of the control or intervention groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Subcommittee on Biomedical Research in Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Science and Heath Services, Faculty of Nursing and Midwifery
City
Qazvin
Province
Qazvin
Postal code
3413768149
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.QUMS.REC.1396.65
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
"Door to balloon" time
Timepoint
Before and after applying "STEMI code"
Method of measurement
Time recording
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group is a patient who has been diagnosed with acute myocardial infarction with ST segment elevation before applying the "STEMI code". and transferring them to "cath lab", using the traditional hospital method.
Category
N/A
2
Description
Intervention group:The intervention group includes patients with acute myocardial infarction, which occurs at a time when the STEMI code is launched. These patients are transmitted to the "Cath lab", by members of the STEMI code (with specific job descriptions).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali sina hospital
Full name of responsible person
Jalalian Fateme
Street address
Naderi Blvd
City
Qazvin
Province
Qazvin
Postal code
3413768149
Phone
+98 28 3333 3031
Email
f54.jalalian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peimani
Street address
Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413768149
Phone
+98 28 3336 6428
Email
f54.jalalian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Jalalian Fateme
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413768149
Phone
+98 28 3336 6428
Email
f54.jalalian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Leili Yekefallah
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Blv, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413768149
Phone
+98 28 3336 6428
Email
leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jalalian Fateme
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413768149
Phone
+98 28 3336 6428
Fax
Email
f54.jalalian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Given the multiple variables measured, and given that the data ultimately result in several articles, I do not plan to publish it.
Study Protocol
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main results of the study are in the form of the article
When the data will become available and for how long
After completing the study and publishing the results as an article
To whom data/document is available
There is no limit to accessing for the results.
Under which criteria data/document could be used
To use its results for future studies.
From where data/document is obtainable
There is no limit to accessing for the results.
What processes are involved for a request to access data/document
Send an email to the owner of the project to receive the documentation.