To compare the carotid intima-media thickness in ultrasound of type II diabetic patients with myocardial infarction requiring primary angioplasty in two groups receiving empagliflozin and placebo.
To compare the carotid intima-media thickness in ultrasound of type II diabetic patients with myocardial infarction requiring primary angioplasty in two groups receiving empagliflozin and placebo.
Design
A randomized, double-blinded clinical trial with a parallel group design of 100 patients, randomized with randomizer software.
Settings and conduct
The double-blind clinical trial (researcher and patient) is parallel. The drugs are coded by the company and given to the patients by the cardiac department, and the radiology department is not involved in prescribing the drugs. The study patients will be randomly selected from type 2 diabetic patients with STEMI, along with the presence of ST-segment elevation above 0.1 mV in two or more leads in the ECG, who were admitted to Ayatollah Mousavi Hospital in Zanjan between August 1402 and September 1402 became. 80 patients are randomly divided into two groups of 40, intervention and control.All patients will be subjected to B-mode and Doppler ultrasound once before the administration of empagliflozin 10 mg/placebo tablets and again after the end of the follow-up period (3 months). All ultrasound examinations will be performed by a radiologist using the SuperSonic imagine ultrasound machine with the SL15-4 Linear probe. Carotid intima-media thickness is measured in the posterior wall of the common carotid artery and in the area without plaque.
Participants/Inclusion and exclusion criteria
inclusion: Type 2 diabetic patients with MI who were previously treated with oral glucose-reducing drugs and patients with STEMI
exclusion: type 1 diabetes _ severe liver failure _ age under 18 years old _ advanced renal failure _ allergy to empagliflozin
Intervention groups
empagliflozin /placebo
Main outcome variables
carotid intima media thickness; resistance index of common carotid and internal carotid ; Atherosclerotic plaques
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230727058945N1
Registration date:2023-08-23, 1402/06/01
Registration timing:registered_while_recruiting
Last update:2023-08-23, 1402/06/01
Update count:0
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
hadi sabat sani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 405 1359
Email address
hs742022@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-13, 1402/05/22
Expected recruitment end date
2023-09-13, 1402/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the carotid intima-media thickness in ultrasound of type II diabetic patients with myocardial infarction requiring primary angioplasty in two groups receiving empagliflozin and placebo.
Public title
Empagliflozin in carotid intima-media thickness
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
type 2 diabetic patients with a history of glucose reducing medications
patients with STEMI with ST-segment elevation more than 0.1mv in two or more leads in ECG
Exclusion criteria:
cardiogenic shock
hypoglycemia
diabetic ketoacidosis
history of coronary artery bypass surgery
type 1 diabetes
severe liver failure
advanced cancer patients
history of allergy to Empagliflozin or ingredients
severe renal failure, ESRD, or dialysis
hypovolemia
inflammatory diseases
Cancer history
advanced heart failure
patients under 18 years of age
pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization. By third-person coding, drug and placebo are divided into two groups, even and odd. With the random allocation rule method, a set of 40 even codes and 40 odd codes are obtained, which is recorded using the randomizer software, and based on that, the medicine is delivered to the patients.
Randomization tool: Randomizer software
Blinding (investigator's opinion)
Double blinded
Blinding description
A person outside the research team labels the drug and placebo, which are both prepared by Abidi Pharmaceuticals, with labels A and B. Blocking of patients by randomizer software will be designed in 4 blocks and written on the sheets and will be chosen randomly by the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
N0.6, Block 4, Zaytoun Complex, 13 East Ave., Karmandan
City
Zanjan
Province
Zanjan
Postal code
1274659009
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.ZUMS.REC.1402.100
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site
2
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Carotid intima-media thickness
Timepoint
Measurement of intima media thickness of carotid artery at the beginning of the study (before the intervention) and 3 months after the start of drug use.
Method of measurement
B-mode and Doppler ultrasound
2
Description
Carotid resistivity index
Timepoint
Measurement of the carotid artery resistivity index at the beginning of the study (before the intervention) and 3 months after starting the drug.
Method of measurement
B-mode and Doppler ultrasound
3
Description
Atherosclerotic plaques
Timepoint
Measurement of atherosclerotic plaques at the beginning of the study (before the intervention) and 3 months after starting the drug.
Method of measurement
B-mode and Doppler ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, 40 type 2 diabetic patients treated with oral drugs, will recieve Empagliflozin from Abidi Pharmaceutical Company in the form of 10 mg tablets,once a day oally for 3 months.
Category
Treatment - Drugs
2
Description
Control group: in this group, 40 type 2 diabetic patients treated with oral drugs, will recieve Placbo made by Abidi Pharmaceutical Company ,once a day oally for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Hadi Sabat sani
Street address
Gavazang Blvd, in front of the University of Basic Sciences
City
Zanjan
Province
Zanjan
Postal code
5618345139
Phone
+98 24 3345 6006
Email
info@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abidi Pharmaceutical Company
Full name of responsible person
Seyed Amir Razavian Ardehali
Street address
No. 72, Abidi Blvd, Kilometer 8 of Shahid Lashkari Highway
City
Tehran
Province
Tehran
Postal code
1389776363
Phone
+98 21 4452 2451
Fax
+98 21 4450 4787
Email
hs742022@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abidi Pharmaceutical Company
Proportion provided by this source
30
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
Industry
2
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Habib Zeighami
Street address
Professor Youssef Sobouti Blvd., Zanjan University of Medical Sciences, Faculty of Medicine
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 0021
Email
Zeighami@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
10
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
Zanjan University of Medical Sciences
Full name of responsible person
Hadi Sabat Sani
Position
MD, radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
N0.6, Block 4, Zaytoun Complex, 13 East Ave., Karmandan
City
Zanjan
Province
Zanjan
Postal code
1274659009
Phone
+98 44 3365 4571
Email
Hs742022@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hadi Sabat Sani
Position
MD, radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
N0.6, Block 4, Zaytoun Complex, 13 East Ave., Karmandan
City
Zanjan
Province
Zanjan
Postal code
1274659009
Phone
+98 44 3365 4571
Email
Hs742022@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hadi Sabat Sani
Position
MD, radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
N0.6, Block 4, Zaytoun Complex, 13 East Ave., Karmandan
City
Zanjan
Province
Zanjan
Postal code
1274659009
Phone
+98 44 3365 4571
Email
Hs742022@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