Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
EMI-STEMI
EMI-STEMI
empty
Adding the abbreviated name of the trial
Adding the abbreviated name of the trial
empty
اضافه کردن نام اختصاری مطالعه
اضافه کردن نام اختصاری مطالعه
Protocol summary
Study aim
Effects of empagliflozin in patients with ST-segment elevation acute myocardial infarction undergoing primary PCI
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Randomization was performed using block randomization method by an independent person.
Settings and conduct
This is a double-blind randomized clinical trial on 100 patients with STEMI undergoing primary PCI at Shahid Madani Heart Center of Tabriz University of Medical Sciences. Patients in the intervention and control groups will receive empagliflozin and a placebo for 40 days. Patients will be compared regarding ST-segment resolution, cardiac troponin I, serum levels of hs-CRP, TIMI flow, ejection fraction, and major adverse cardiac events. In this study, none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) patients with STEMI undergoing primary PCI
2) Age between 18 to 80 years 3) Ability to understand and sign the consent form Exclusion criteria: 1) Pregnancy 2) Breastfeeding 3) Kidney failure (eGFR < 30) 4) Liver failure 5) Systolic blood pressure below 100 mmHg
6) Inflammatory and autoimmune diseases 7) Diabetes mellitus 8) Chronic heart failure 9) Malignancy 10) Psychiatric disorders 11) Contraindications to empagliflozin 12) History of empagliflozin use13) History of myocardial infarction 14) Arrival more than 6 hours from symptoms onset
Intervention groups
Patients in the intervention group will receive 10 mg of empagliflozin daily for 40 days in addition to standard treatments.
Main outcome variables
1) ST-segment resolution 2) Cardiac troponin I 3) hs-CRP 4) Ejection fraction 5) Major adverse cardiac events
General information
Reason for update
Adding the abbreviated name of the trial
Acronym
EMI-STEMI
IRCT registration information
IRCT registration number:IRCT20111206008307N42
Registration date:2022-11-19, 1401/08/28
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:3
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Empagliflozin effects in patients with ST-elevation myocardial infarction undergoing primary PCI: a randomized clinical trial
Public title
Empagliflozin effects in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with STEMI undergoing primary PCI
Patients aged between 18 to 80 years
Consented patients
Exclusion criteria:
Pregnancy
Lactation
Renal failure (eGFR < 30)
Hepatic failure
Systolic blood pressure less than 100 mmHg
Inflammatory and autoimmune diseases
Diabetes mellitus
Chronic heart failure
Cancer
Psychiatric disorders
Empagliflozin contraindications
History of receiving empagliflozin
History of myocardial infarction
Arrival more than 6 hours from symptoms onset
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
En Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind and none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups. For this purpose, empagliflozin and placebo will be similarly packaged and given to the patient. Also, empagliflozin and placebo tablets will have the same shape, color, and size.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.TBZMED.REC.1401.695
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
ST-segment resolution
Timepoint
Before and 90 min after primary percutaneous coronary intervention
Method of measurement
Electrocardiogram
2
Description
Cardiac troponin I
Timepoint
At baseline and then every 6 hours for the first 24 hours and every 12 hours to 72 hours after admission
Method of measurement
Laboratory test
3
Description
High-sensitivity C-reactive protein (hs-CRP)
Timepoint
Before primary percutaneous coronary intervention and at discharge
Method of measurement
Laboratory test
4
Description
Cardiac ejection fraction
Timepoint
At baseline and 40 days after intervention
Method of measurement
Echocardiography
5
Description
TIMI flow
Timepoint
Before and after primary percutaneous coronary intervention
Method of measurement
Angiography
6
Description
Major adverse cardiac events
Timepoint
Within 40 days after primary percutaneous coronary intervention
Method of measurement
Interview
7
Description
Quality of life
Timepoint
At baseline and 40 days after primary percutaneous coronary intervention
Method of measurement
MacNew questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 10 mg empagliflozin daily for 40 days in addition to usual treatments.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive a placebo daily for 40 days along with usual treatments.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Medical & Training Hospital
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Daneshgah Street, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3901
Email
tentezari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari Maleki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Madani Center, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 5983
Email
tentezari@gmail.com
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of an article can be published after making patients unrecognized.
When the data will become available and for how long
After publishing of article until 6 months after publishing of the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers who request data will be permitted only to do analysis according to ethics for scientific aims.
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.
What processes are involved for a request to access data/document
After contacting the corresponding author(Dr. Taher Entezari Maleki), data will be sent to the Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be sent to applicants.