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Evaluation the effect of colchicine on the outcome and noreflow of blood in the coronary arteries in patients undergoing primary percutaneous coronary intervention in patients with acute myocardial infarction

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History
# Registration date Revision Id
2 2024-06-01, 1403/03/12 304041
1 2023-08-09, 1402/05/18 274744
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  • General information

    240
    120
    2024-05-20, 1403/02/31
    2024-04-19, 1403/01/31
    empty
    Changing the sample size Due to the reduction of the cold weather last year (and as a result the reduction of angina pectoris last year) and due to the failure of the cat lab of Seyed Al-Shohada Center and the lack of a suitable stent size for several months, a large number of acute myocardial infarction patients were treated with thrombolytics and removed from my study. After consulting with the supervisor and statistical consultant, while maintaining the power of the study and according to the statistical formula, the sample size was reduced to at least 120 samples (at least 60 samples in each group) by the statistician.
    empty
    تغییر حجم نمونه با توجه به کاسته شدن از برودت هوا در سال گذشته ( و در نتیجه کاهش آنژین قلبی در سال گذشته ) و به علت خرابی کت لب مرکز سیدالشهدا و نبود استنت سایز مناسب برای چند ماه موجب شده که تعداد زیادی از بیماران سکته قلبی حاد تحت درمان با ترومبولیتیک قرار گرفته و از مطالعه اینجانب خارج شدند . بعد از مشورت با استاد راهنما و مشاور آماری با حفظ قدرت مطالعه و طبق فرمول آماری ، توسط متخصص آمار حجم نمونه به حداقل 120 نمونه ( در هر گروه حداقل 60 نمونه) تقلیل یافت.

  • Recruitment centers

    #1
    Name of recruitment center - English: Seyyed al-Shohda Heart Hospital Urmia
    Name of recruitment center - Persian: بیمارستان قلب سیدالشهدا ارومیه
    Full name of responsible person - English: ozra kahourian
    Full name of responsible person - Persian: عذرا کهوریان
    Street address - English: 17 Shahrivar Blvd., in front of Samadzadeh St., Seyed al-Shohada Heart Hospital
    Street address - Persian: بلوار 17 شهریور ، روبروی خیابان صمدزاده ، بیمارستان قلب سیدالشهدا
    City - English: urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5718748983
    Phone: +98 44 3237 5907
    Fax:
    Email: kahourian.ozra@gmail.com
    Web page address:
    Name of recruitment center - English: Seyyed Al-Shohda Heart Hospital Urmia
    Name of recruitment center - Persian: بیمارستان قلب سیدالشهدا ارومیه
    Full name of responsible person - English: Ozra Kahourian
    Full name of responsible person - Persian: عذرا کهوریان
    Street address - English: 17 Shahrivar Blvd., in front of Samadzadeh St., Seyed Al-Shohada Heart Hospital
    Street address - Persian: بلوار 17 شهریور ، روبروی خیابان صمدزاده ، بیمارستان قلب سیدالشهدا
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5718748983
    Phone: +98 44 3237 5907
    Fax:
    Email: kahourian.ozra@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: ozra kahourian
    Full name of responsible person - Persian: عذرا کهوریان
    Street address - English: Urmia University of Medical Sciences, Resalat Blvd., Emergency Alley
    Street address - Persian: بلوار رسالت ، کوی اورژانس ، ستاد دانشگاه علوم پزشکی ارومیه
    City - English: urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5714783734
    Phone: +98 44 3223 4897
    Fax:
    Email: kahourian.ozra@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ozra Kahourian
    Full name of responsible person - Persian: عذرا کهوریان
    Street address - English: Urmia University of Medical Sciences, Resalat Blvd., Emergency Alley
    Street address - Persian: بلوار رسالت ، کوی اورژانس ، ستاد دانشگاه علوم پزشکی ارومیه
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5714783734
    Phone: +98 44 3223 4897
    Fax:
    Email: kahourian.ozra@gmail.com
    Web page address:

Protocol summary

Study aim
Investigating the effect of colchicine on the outcome and lack of reflow of blood in the coronary arteries in patients undergoing primary percutaneous coronary intervention in acute myocardial infarction patients.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 350 patients in a randomized manner
Settings and conduct
Patients with acute heart attack referred to Seyed al-Shohadah center who will undergo initial percutaneous intervention will be randomly treated with colchicine, and then the phenomenon of no reflow of blood in the coronary arteries and other outcomes will be recorded and will be evaluated
Participants/Inclusion and exclusion criteria
Patients aged 18 to 80 who had ST elevation myocardial infarction for the first time and underwent percutaneous primary intervention will be included in the study. Exclusion criteria include: hemodynamic instability, liver failure, kidney failure , history of blood disease and chronic use of colchicine.
Intervention groups
Patients will receive an equal amount of colchicine or placebo at the time closest to PCI. Patients in the case group will receive 2 mg oral colchicine as a loading dose, then 0.5 mg colchicine twice a day for 30 days. Loading dose must be given to patients before PCI and it is not possible to administer it after PCI.
Main outcome variables
Checking TIMI FLOW before and after stent implantation, checking the amount of TROPONIN at the beginning and 24 and 48 hours later, checking the amount of CRP at the beginning and 48 hours later, determining the occluded vessel that led to AMI, checking LVEF before Discharge, check for MACE (major adverse cardiac events which include target vessel revascularization, target lesion revascularization, new hospitalization due to heart failure, stroke, nonfatal myocardial infarction, and cardiac death) for one month

General information

Reason for update
Changing the sample size Due to the reduction of the cold weather last year (and as a result the reduction of angina pectoris last year) and due to the failure of the cat lab of Seyed Al-Shohada Center and the lack of a suitable stent size for several months, a large number of acute myocardial infarction patients were treated with thrombolytics and removed from my study. After consulting with the supervisor and statistical consultant, while maintaining the power of the study and according to the statistical formula, the sample size was reduced to at least 120 samples (at least 60 samples in each group) by the statistician.
Acronym
IRCT registration information
IRCT registration number: IRCT20230620058546N1
Registration date: 2023-08-09, 1402/05/18
Registration timing: registered_while_recruiting

Last update: 2024-06-05, 1403/03/16
Update count: 1
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
ozra kahourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3235 7473
Email address
kahourian.ozra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of colchicine on the outcome and noreflow of blood in the coronary arteries in patients undergoing primary percutaneous coronary intervention in patients with acute myocardial infarction
Public title
Evaluation the effect of colchicine on acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have ST elevation myocardial infarction and are candidates for primary percutaneous intervention
Exclusion criteria:
Hemodynamic instability liver failure kidney failure history of blood disease chronic colchicine use
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (100 patients), 25 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher gave the drug and the placebo, which had the same appearance, to the emergency doctor in the same numbered packages (only the researcher knows the type of drugs in the packages) and the emergency doctor block randomly prescribed the mentioned drugs to heart attack patients and the doctor interpreted The angiographer and the doctor who performs the echocardiography do not know the type of drug the patient is taking, and in the last step, before analyzing the data, the type of the patient's drug is extracted by the researcher from the list by the number of the drug envelope, and then the data is extracted is analyzed by the statistician.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
17 Shahrivar Blvd., in front of Samad Zadeh St., Seyed al-Shohada Heart Hospital
City
urmia
Province
West Azarbaijan
Postal code
5718748983
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.UMSU.REC.1402.019

Health conditions studied

1

Description of health condition studied
Patients with acute heart attack
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Investigation of TIMI flow rate in coronary arteries after stent placement in acute myocardial infarction patients
Timepoint
After the intervention and at the beginning of the study
Method of measurement
Judgment by cardiologist after angiography

Secondary outcomes

1

Description
Examination of the small amount of TROPONIN
Timepoint
at admission and 24 and 48 hours later
Method of measurement
in the laboratory by quantitative troponin kits

2

Description
Investigating the increase of CRP
Timepoint
at the beginning of hospitalization and 48 hours later
Method of measurement
Measurement by quantitative kits in the laboratory

Intervention groups

1

Description
Intervention group: 2 mg of oral colchicine as a loading dose (two tablets) then 0.5 mg (half a tablet) of colchicine twice a day (every 12 hours) for 30 days
Category
Treatment - Drugs

2

Description
Control group: two placebo tablets (manufactured in Keihan Daru Chemi factory located at kilometer seventeen of Urmia city road towards Mahabad city) and then half a placebo tablet every 12 hours for 30 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyyed Al-Shohda Heart Hospital Urmia
Full name of responsible person
Ozra Kahourian
Street address
17 Shahrivar Blvd., in front of Samadzadeh St., Seyed Al-Shohada Heart Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
kahourian.ozra@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ozra Kahourian
Street address
Urmia University of Medical Sciences, Resalat Blvd., Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
kahourian.ozra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Ozra Kahourian
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 114, Alley 6, Mafi Street, Modyriat Street
City
Urmia
Province
West Azarbaijan
Postal code
5714794616
Phone
+98 44 3235 7473
Email
kahourian.ozra@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ozra Kahourian
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No.114 , Alley 6 , Modyriat St., Maffei St.
City
Urmia
Province
West Azarbaijan
Postal code
5714794616
Phone
+98 44 3235 7473
Email
kahourian.ozra@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ozra Kahourian
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No.114 , Alley 6 , Modyriat St., Maffei St.
City
Urmia
Province
West Azarbaijan
Postal code
5714794616
Phone
+98 44 3235 7473
Email
kahourian.ozra@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
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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