Protocol summary

Study aim
The main goal of this study is to investigate the effect of squalene on the improvement of clinical, laboratory and imaging symptoms in patients with acute heart failure due to acute myocardial infarction.
Design
Clinical trial with a control group, with a parallel group, randomized, on 88 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients with acute myocardial infarction who were admitted to Imam Reza Hospital randomly divided into two groups , receiving squalene drops in addition to routine treatments and a control group (only receiving treatment) routines). Also, treatment with squalene drops will be done 4 times a day with a dose of 5 drops each time for 5 days. Patients undergo hemodynamic, echocardiographic and necessary tests in the first 24 hours before starting the drug and then after 30 days.
Participants/Inclusion and exclusion criteria
The criteria for entering the study will be acute anterior myocardial infarction with an ejection fraction of less than 40%, who are admitted to Imam Reza Hospital. Patients with underlying kidney disease or underlying heart disease or a history of coronary bypass are excluded from the study.
Intervention groups
Patients with anterior acute myocardial infarction with EF less than 40% who receive squalene in addition to routine treatments are the intervention group and patients with anterior acute infarction with ejection fraction less than 40% who are studied as control group and only conventional drugs And they receive routine heart disease, they are the control group of the study.
Main outcome variables
Echocardiographic parameters such as: ejection fraction, abnormality of valve motion, diastolic failure, pulmonary artery pressure, and valvular insufficiency. Hemodynamic parameters such as: initial blood pressure,presence or absence of pulmonary rales, blood oxygen saturation percentage.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221021056258N1
Registration date: 2022-11-13, 1401/08/22
Registration timing: registered_while_recruiting

Last update: 2022-11-13, 1401/08/22
Update count: 0
Registration date
2022-11-13, 1401/08/22
Registrant information
Name
Alireza Fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 697 2992
Email address
fazelia981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Biological and Pharmacological Activities Of Squalene,Potential Uses In Acute Myocardial Infarction
Public title
Biological and Pharmacological Activities Of Squalene In Acute Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 80 years old Patients who have been diagnosed with ST segment elevation myocardial infarction and have undergone successful vascularization with angioplasty in the vessel related to the infarct. Ejection fraction less than forty percent in the field of acute Myocardial infarction
Exclusion criteria:
Ventricular arrhythmia Congenital heart disease Suspected or documented history of heart failure or decreased ejection fraction (EF) of the left ventricle CABG candidate patients or previous CABG history GFR less than 30 People with autoimmune diseases or connective tissue disease People with cancer Pregnant and lactating women Psychiatric patients and people who cannot complete the one-month clinical follow-up during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
First, the random sequence is generated using www.randomization.com. Then, based on the size of the research sample, a number of envelopes with aluminum wrappers (in order not to make the contents of the envelopes unclear) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of patient sampling, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
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 Mashhad University of Medical Sciences
Street address
Imam reza hospital., Ahmadabad Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
5467534564
Approval date
2022-04-11, 1401/01/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.182

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21.0
ICD-10 code description
ST elevation (STEMI) myocardial infarction of anterior wall

2

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Ejection fraction
Timepoint
Patients undergo echocardiography in the first 24 hours before starting the drug and then after 30 days.
Method of measurement
Echocardiography

Secondary outcomes

1

Description
Wall motion abnormality
Timepoint
Before starting the medicine and also thirty days after starting the medicine.
Method of measurement
Echocardiography

2

Description
Diastolic dysfunction
Timepoint
Before starting the medicine and also thirty days after starting the medicine.
Method of measurement
Echocardiography

3

Description
Pulmonary arterial pressure
Timepoint
Before starting the medicine and also thirty days after starting the medicine.
Method of measurement
Echocardiography

4

Description
Valvular Dysfunction
Timepoint
Before starting the medicine and also thirty days after starting the medicine.
Method of measurement
Echocardiography

5

Description
Laboratory factors such as complete blood cell count.
Timepoint
Before starting the drug and after thirty days from the start of the drug.
Method of measurement
Laboratory kit.

Intervention groups

1

Description
Intervention group: In addition to routine treatments, the group receiving squalene drops will receive sublingually and 4 times a day with a dose of 5 drops each time for 5 days. The concentration of the drug is ten milligrams per milliliter and with It is produced by the collaboration of Mashhad Faculty of Medical Sciences and professors of pharmacy and chemical engineers of the Faculty of Basic Sciences of Ferdowsi University of Mashhad.Squalene extracted from vegetable oils is a non-toxic and biocompatible lipid that has various applications in the food and pharmaceutical industries. Also, this compound is a precursor of cholesterol and one of the natural components of human skin and protects it against radiation. So far, its anti-inflammatory, antioxidant and anti-tumor properties have been investigated and proven in animal studies, and no toxicity and or adverse effects have not been reported in animals.
Category
Treatment - Drugs

2

Description
Control group: Only recipients of routine treatments for acute myocardial infarction and heart failure.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza Hospital
Full name of responsible person
Alireza fazeli
Street address
Bahar Ave., Ahmadabad Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
3456476985
Phone
+98 51 3854 3031
Email
fazelia981@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayoor Mobarhan
Street address
Imam reza hospital,Ahmadabd Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
4356798768
Phone
+98 51 3854 3031
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza fazeli
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 5, Saremi Ave., Vakilabad Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
476876543564
Phone
+98 51 3843 5676
Email
fazelia981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza fazeli
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 5, Saremi Ave., Vakil abad Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
6547698743
Phone
+98 51 3832 4567
Email
fazelia981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Fazeli
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 5, Saremi Ave., Vakilabad Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
6547898765
Phone
+98 51 3854 3017
Email
fazelia981@mums.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
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