Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers
Design
This study is a clinical trial with control group and double blind randomized parallel groups in which 352 eligible patients will be randomly assigned to intervention and control groups
Settings and conduct
Patients with ACS referred to Golestan and Imam Khomeini hospitals will be included in the study if eligible
Participants/Inclusion and exclusion criteria
Patients with acute myocardial infarction
Intervention groups
First group: receive O2 as interventional medication
Second group: receive environmental air as placebo
Main outcome variables
Cardiac bio-markers (in our study troponin), as the most important indicator of our study, will be measured at 2 locations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190922044850N1
Registration date:2019-10-10, 1398/07/18
Registration timing:retrospective
Last update:2019-10-10, 1398/07/18
Update count:0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
Ehsan Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3227 5806
Email address
dr.ehsan.kiani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers
Public title
the Role of Oxygen in Suspected Acute Myocardial Infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of ACS (Acute coronary syndrome) in patients
Lack of O2 intake in other centers
Lack of history of Heart Failure
Lack of history of COPD (Chronic obstructive pulmonary disease)
Lack of history of respiratory diseases
Exclusion criteria:
Need for Inotropic agents
So2 less than 90%
Dissatisfaction
Admission less than 6 hours in hospital
Unstable vital signs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
350
Actual sample size reached:
352
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the blinded study, neither the researcher nor the patients would know the type of gas received, the study was double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commette of AJUMS
Street address
No 10, 20 Eghbal Ave, Kourosh, Ahwaz, khouzestan, Iran
City
Ahwaz
Province
Khouzestan
Postal code
46416164
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.AJUMS.REC.1397.397
Health conditions studied
1
Description of health condition studied
Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers
ICD-10 code
I21.9
ICD-10 code description
Acute myocardial infarction, unspecified
Primary outcomes
1
Description
Troponin
Timepoint
On arrival and 4-6 hours after the patients arrive at the emergency department
Method of measurement
Blood sample
2
Description
LVEF(Left Ventricular Ejection Fraction)
Timepoint
On arrival and 4-6 hours after the patients arrive at the emergency department
Method of measurement
Eco cardiography
3
Description
arrhythmia
Timepoint
On arrival and 4-6 hours after the patients arrive at the emergency department
Method of measurement
ECG (Electrocardiogram)
4
Description
heart pain
Timepoint
On arrival and 4-6 hours after the patients arrive at the emergency department
Method of measurement
Asking the patient
5
Description
Opioid drugs
Timepoint
On arrival and 4-6 hours after the patients arrive at the emergency department
Method of measurement
Based on the mg prescribed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with ACS referred to Golestan and Imam Khomeini teaching hospitals of Ahwaz with inclusion criteria who will be given oxygen by nasal method for 4-6 hours at 4-6 liters / min and According to the blinding done, neither the researcher nor the patients will know the type of gas received.
Category
Diagnosis
2
Description
Control group: control group:Patients with ACS referred to Golestan and Imam Khomeini teaching hospitals of Ahwaz with inclusion criteria who will be given Room air by nasal method for 4-6 hours at 4-6 liters / min and According to the blinding done, neither the researcher nor the patients will know the type of gas received.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital golestan university
Full name of responsible person
Ehsan Kiani
Street address
Golestan Educational and Medical Center, Farvardin Street, Golestan, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3014
Email
golestanhospital@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Ehsan Kiani
Street address
mam Khomein hospital, Azadegan Street, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
No 10, 20 Eghbal Ave, Kourosh, Ahwaz, khouzestan, Iran
City
Ahwaz
Province
Khouzestan
Postal code
46416164
Phone
+98 61 3336 2414
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Kiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Floor 2, Unit 6, No. 10, Building Complex, 20 Eghbal Ave, Kourosh, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
4641616479
Phone
+98 61 3227 5806
Email
Dr.ehsan.kiani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Kiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Floor 2, Unit 6, No. 10, Building Complex, 20 Eghbal Ave, Kourosh, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
4641616479
Phone
+98 61 3227 5806
Email
Dr.ehsan.kiani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Kiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Floor 2, Unit 6, No. 10, Building Complex, 20 Eghbal Ave, Kourosh, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
4641616479
Phone
+98 61 3227 5806
Email
Dr.ehsan.kiani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available