Effect of normal saline intra-coronary injection versus no injection on the complications of re-perfusion during primary angioplasty in patients with acute myocardial infarction: a randomized clinical trial
To assess the effect of normal saline intracoronary injection versus no injection on the complications of reperfusion during primary angioplasty in patients with acute myocardial infarction
Design
This is a randomized clinical trial, in which 30 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with acute myocardial infarction who will refer to Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Acute myocardial infarction,
ST-elevation
Exclusion criteria:
Need for cardiac surgery
Intervention groups
Intervention group:
Routine angioplasty plus an injection of normal saline at 22 ° C at a speed of 20 ml/min into the coronary artery for 10 minutes
Control group:
Routine angioplasty
Main outcome variables
Primary outcome:
Heart perfusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N316
Registration date:2019-11-14, 1398/08/23
Registration timing:registered_while_recruiting
Last update:2019-11-14, 1398/08/23
Update count:0
Registration date
2019-11-14, 1398/08/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of normal saline intra-coronary injection versus no injection on the complications of re-perfusion during primary angioplasty in patients with acute myocardial infarction: a randomized clinical trial
Public title
Effect of normal saline intra-coronary injection versus no injection on the complications of re-perfusion during primary angioplasty in patients with acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Acute myocardial infarction,
ST-elevation
Exclusion criteria:
Need to cardiac surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.UMSHA.REC.1397.478
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I22.9
ICD-10 code description
Subsequent ST elevation (STEMI) myocardial infarction of unspecified site
Primary outcomes
1
Description
Heart perfusion
Timepoint
Before the intervention and 30 days after that
Method of measurement
By echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine angioplasty plus an injection of normal saline at 22 ° C at a speed of 20 ml/min into the coronary artery for 10 minutes
Category
Treatment - Drugs
2
Description
Control group: Routine angioplasty without an injection of normal saline
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Dr Mahshid Mokhayari
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
s.zebarjadi65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahshid Mokhayari
Position
Resident of Cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
s.zebarjadi65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahshid Mokhayari
Position
Resident of Cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
s.zebarjadi65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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