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Investigating the effect of Mebourein drug on the clinical symptoms of patients with slow coronary flow

Protocol summary

Study aim
Determining the effect of Mebourein on the clinical symptoms of patients with slow coronary flow phenomenon
Design
A clinical trial with a control group, with parallel groups, three blinded, without randomization, phase 3 on 100 patients.
Settings and conduct
One hundred patients referred for diagnostic angiography were selected to Tehran heart center during 2024 and divided into 2 groups of 50 people (intervention and control). Meborin oral drug will be given in a 3-blind design (blind people:patients, patient's family and outcome evaluator) with a dose of 200 mg every 12 hours, and the other group will be given a placebo drug with the same amount and duration. After 1 month, the changes in the clinical symptoms of the patients in the two groups will be evaluated by a specialist doctor in the clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Angiography due to chronic symptoms or positive non-invasive test under angiography/TIMI frame count > 27/contrast not reaching the end of the coronary arteries after 3 heartbeats Exclusion criteria: lack of consent or non-cooperation/ failure to visit the heart clinic regularly/ history of heart failure in echocardiography and valvular disease or any other heart disease/ suffering from acute coronary events and vascular ectasia/ involvement of more than 50% of vessels Epicardial
Intervention groups
In the intervention group, Mebourein oral drug with a dose of 200 mg will be given every 12 hours for one month and one tablet each time. In the control group, the placebo drug, which is similar in shape, color and smell to Mebourein, will be given every 12 hours for one month and one pill each time.
Main outcome variables
Changes in patients' clinical symptoms, including chest pain, functional chest pain, and functional shortness of breath.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240613062116N1
Registration date: 2024-06-17, 1403/03/28
Registration timing: prospective

Last update: 2024-06-17, 1403/03/28
Update count: 0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
Nazanin Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
research.medicine20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Mebourein drug on the clinical symptoms of patients with slow coronary flow
Public title
Mebourein in slow coronary flow symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Performing diagnostic angiography due to chronic symptoms or positive non-invasive test TIMI frame count greater than 27 in angiography In the injection of angiography contrast material, after 3 heartbeats, the contrast material has not reached the end of the coronary arteries in patients.
Exclusion criteria:
Non-satisfaction or non-cooperation in taking Mebourein or placebo Failure to visit the heart clinic regularly within 1 month of angiography History of heart failure in echocardiography Any patient who has a history of valvular disease or any other heart disease Patients who experience acute coronary events during this period Patients with vascular ectasia Involvement of more than 50% of epicardial vessels
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients and the person who gives the medicine to the patient and the person who checks the patient's information after taking it do not know the type of medicine used by the patient. According to the code of the medicine obtained in advance by the responsible nurse, the medicine or placebo is prescribed to the patient by the doctor.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416633591
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.TUMS.THC.REC.1402.028

Health conditions studied

1

Description of health condition studied
Slow coronary flow
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris

Primary outcomes

1

Description
Clinical symptoms of patients including chest pain, functional chest pain and functional shortness of breath
Timepoint
One month after the first visit and drug consumption
Method of measurement
Evaluation and questioning of patients by a specialist doctor and registration in the checklist.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, Mebourein oral tablet with a dose of 200 mg every 12 hours will be given to patients in the intervention group in the form of one tablet for one month.
Category
Treatment - Drugs

2

Description
Control group: In this group, the placebo tablet, which is similar in color, shape and size to Mebourein tablets, will be given to the patients of the control group with a dose of 200 mg every 12 hours in the form of one tablet for one month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Alireza Amirzadeghan
Street address
Jalal Al Ahmad Highway, North Kargar Street.
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Karimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 81631
Email
research.medicine20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Amirzadeghan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 81631
Email
research.medicine20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Karimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 81631
Email
research.medicine20@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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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