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Evaluation of effects of Colchicine on corrected Thrombolysis In Myocardial Infarction (TIMI) frame in ST segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention (PPCI)

Protocol summary

Study aim
assessment of Colchicine effect in improvement of PPCI in patients with STEMI
Design
double blind randomized clinical trial which will be done in 60 patients with STEMI between May 2017 and May 2018.
Settings and conduct
The investigation will be performed in Imam Reza and Qaem Hospitals in Mashhad and Colchicine and placebo will be coded by pocket and researcher and patient will be blinded to its content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: stability for at least previous 6 months, ability for participation in followups, consent for enter in the study, Anterior ST elevation MI Exclusion criteria: contraindication of Colchicine consumption, Infectious disorder or active inflammatory disorder or known malignancy, current treatment by Corticosteroid or other anti-inflammatory drugs, known sensitivity to Colchicine or current treatment by Colchicine, severe renal failure (GFR<30), liver failure, cardiac arrest, ventricular fibrillation or symptomatic cardiogenic shock, stent thrombosis, occurrence of angina 48 hours before infarction, previous myocardial infarction, left main coronary artery or left circumflex occlusion, existence of metal implant, pregnancy
Intervention groups
Patients with anterior STEMI in last 12 hours presented by chest pain and referred to Qaem and Imam Reza Hospitals and first will undergo angiography then PCI will entered in the study and randomly will be assigned in intervention (treatment by Colchicine) and control (treatment by placebo) groups.
Main outcome variables
PPCI result improvement by corrected TIMI frame count

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180127038515N1
Registration date: 2018-03-19, 1396/12/28
Registration timing: registered_while_recruiting

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Samaneh Hassanzadeh Avval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
s.hassanzadeh1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of Colchicine on corrected Thrombolysis In Myocardial Infarction (TIMI) frame in ST segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention (PPCI)
Public title
Effect of Colchicine in improvement of myocardial infarction patients undergoing therapeutic intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stability for at least previous 6 months ability for participation in followups consent for enter in the study
Exclusion criteria:
contraindication of Colchicine consumption infectious disorder or active inflammatory disorder or known malignancy current treatment by Corticosteroid or other anti-inflammatory drugs known sensitivity to Colchicine or current treatment by Colchicine severe renal failure (GFR<30) liver failure cardiac arrest ventricular fibrillation or symptomatic cardiogenic shock stent thrombosis occurrence of angina 48 hours before infarction previous myocardial infarction left main coronary artery or left circumflex occlusion existence of metal implant pregnancy
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and researcher will be blinded by coded-pockets toward administrating drugs.
Placebo
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
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2017-01-04, 1395/10/15
Ethics committee reference number
IR.MUMS.fm.REC.1395.487

Health conditions studied

1

Description of health condition studied
ST segment elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
corrected TIMI frame count index
Timepoint
before starting PCI, after doing PCI
Method of measurement
By using angiography device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: administration of 2mg Colchicine
Category
Treatment - Drugs

2

Description
Control group: administration of 2mg placebo tablet
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Eshraghi
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
eshraghia@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/index.php

2

Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Ramin Khamene Bagheri
Street address
Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
919991766
Phone
+98 51 3840 0000
Email
khamenehbr@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/index.php

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
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Web page address
http://v-research.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
Samaneh Hassanzadeh Avval
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shariati Sqaure
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3854 3031
Fax
Email
s.hassanzadeh1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ramin Khameneh Bagheri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular department, First floor, Qaem Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0000
Email
khamenehbr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Hassanzadeh Avval
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shariati Sqaure
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3854 3031
Fax
Email
s.hassanzadeh1@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Article in journals and report in conferences and seminar
When the data will become available and for how long
unlimited
To whom data/document is available
general academic or non-academic researcher
Under which criteria data/document could be used
By getting permission from main researcher of this project
From where data/document is obtainable
main researcher of project
What processes are involved for a request to access data/document
sending request to main researcher of the project and after validation the data will be send to requester
Comments
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