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Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction with ST elevation segment: a triple-blind, randomized, placebo-controlled trial

Protocol summary

Study aim
Investigating the oxygen-boosting effects of trans-sodium crocetinate and its properties in reducing the complications of reperfusion in acute myocardial infarction with ST-segment elevation.
Design
A randomized clinical trial, on 100 patients (two groups of 50 people), block randomization (via randomization site), parallel groups, triple-blind, phase 3.
Settings and conduct
The main medication, trans sodium crosetinate, is made in Mashhad School of Pharmacy in accordance with the principles of GLP, in addition to placebo, which is similar to the main medication in terms of vial shape and color. This study is performed in the heart ward of Imam Reza hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Age between 18 and 76 years; myocardial infarction with an ascending ST segment; having AHA 2019 guideline criteria; candidates for PCI; zero TIMI score at admission.
Intervention groups
Intervention group: Patients under PPCI who receive TSC (trans sodium crocetinate) at a dose of 0.5 mg per body weight by injection within 2 minutes, 5 minutes before PCI, in addition to standard treatments for acute myocardial infarction, and then on days 0 to 3, patients receive 7.5 mg crosin tablets daily for 3 days. Control group: Patients under PCI who, in addition to standard treatments for acute myocardial infarction, receive a placebo vial that is injected within 2 minutes, 5 minutes before PCI, and then on days 0 to 3, Placebo tablets are taken 3 tablets a day for 3 days.
Main outcome variables
Quantitative amounts of troponin I(Tn I) enzyme

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120520009801N5
Registration date: 2021-09-13, 1400/06/22
Registration timing: prospective

Last update: 2021-09-13, 1400/06/22
Update count: 0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction with ST elevation segment: a triple-blind, randomized, placebo-controlled trial
Public title
Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 18 and 76 years old Patients with myocardial infarction with an ascending ST segment Meet the entry requirements under the AHA2019 guideline Candidates for PPCI Zero TIMI score at admission
Exclusion criteria:
Be pregnant or breastfeeding History of allergy to formulations used in the study.• The patient enters another similar plan and receives other drugs that affect treatment response in the past month The person has cardiogenic shock and is forced to use pressure therapy The patient has IABP History of acute myocardial infarction GFR less than 60 ml / min• Patients with cardiac arrest Patient with VF Patient with hepatic impairment AST / ALT> 5ULN Patient with a history of chronic inflammatory disease Patient with LMCA involvement Patient with a history of myocardial infarction or ACS within 4 hours before the current episode
Age
From 18 years old to 76 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Alternate block randomization using www.randomization.com. Each block has 4 components and the mentioned site selects twenty-five blocks out of quadruple blocks randomly, so finally 100 patients are included in the study. The allocation concealment method is by use of opaque sealed envelopes with random sequences obtained from the random allocation step.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The vials will be marked with the letters A and B, and since the placebo will also be made by the Industrial Department of the School of Pharmacy, we will not have a problem with masquerade. It will be the same with pills. Physician, injecting drug nurse, clinical pharmacy resident, patients, and results analyzer will remain unaware of the type of formulation until completed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah stree
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Approval date
2021-08-11, 1400/05/20
Ethics committee reference number
IR.MUMS.REC.1400.131

Health conditions studied

1

Description of health condition studied
STEMI
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site

Primary outcomes

1

Description
Quantitative amounts of Troponin I Tn I enzyme and drawing the shape of the Tn I time concentration curve
Timepoint
At zero time, 6, 12 and 24 hours after PPCI
Method of measurement
High-Sensitivity Troponin Test-Laboratory

Secondary outcomes

1

Description
Evaluation of the patient's electrocardiogram and recording of ventricular and supraventricular arrhythmias, number of PVCs, PR / QT / QRS intervals, and evaluation of the cumulative amount of ST segment (STR Percentage)
Timepoint
Daily until discharge
Method of measurement
Through ECG examination

2

Description
Ejection fraction and evaluation of systolic and diastolic status of all 4 chambers of the heart and LV ENLARGMENT
Timepoint
Daily until discharge
Method of measurement
Echocardiography

3

Description
Evaluation of biochemical parameters INR, BUN, Scr Na, K, Ca, Mg, ALT, AST
Timepoint
Daily until discharge
Method of measurement
Laboratory

4

Description
Evaluation of the balance between oxidants - antioxidants
Timepoint
Two samples at time zero and patient discharge time
Method of measurement
Laboratory

Intervention groups

1

Description
Intervention group: Patients under PCI who receive trans sodium crocetinate"""(TSC) at a dose of 0.5 mg / kg body weight by injection within 2 minutes, 5 minutes before PCI, in addition to standard treatments for acute myocardial infarction, then take crocetin oral tablets on days 0 to 3 At a dose of 7.5 mg, they take 3 tablets a day
Category
Prevention

2

Description
Control group: Patients under PCI receive normal saline at a dose of .05 mg/v in addition to standard treatments for acute myocardial infarction within 2 minutes, 5 minutes before PCI, and then 3 placebo tablets on days 0 to 3.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Raza hospital
Full name of responsible person
Amirhooshang Mohamadpoor
Street address
Imam Raza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3854 3031
Email
support@rpsi.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah street., Ghoreyshi bulding
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
mohamadpoorah@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
mohamadpoorah@mums.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
only available for people working in academic institutions and there is not another condition
From where data/document is obtainable
mohamadpoorah@mums.ac.ir
What processes are involved for a request to access data/document
mohamadpoorah@mums.ac.ir
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