Effect of high dose of Allopurinol loading on level of inflammatory markers and in hospital composite events in Non ST-segment elevation myocardial infarction patients who refer to chamran hospital in Esfahan city.
Determination of the effect of high dose allopurinol on inflammatory markers and intra-hospital complications of the patients with acute myocardial infarction without ST elevation
Design
A double-blinded randomized clinical trial with parallel groups, with a control group
Settings and conduct
The current study will be conducted in the Specialized Cardiac center of Chamran in Isfahan during 2019-2021. In this study, the number of 40 patients will be treated with a loading dose of 600 mg of allopurinol before angiography and the latter 40 ones will be treated with a placebo. The patient's allocation to case or control group will be done using Random Allocation software in which each patient will be provided with a particular number to allocate him/her to one of the study groups. The researcher is not aware of the patient's treatment protocol and will be blinded. Besides, the groups will be shown as numbers 1 and 2 for the statistician and the statistician is blinded as well.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Typical chest pain for ischemia,'
Lacking ST-segment elevation in two adjacent leads,
Seropositivity for cardiac troponin,
The patient's willingness for participation in the study,
The age range of 18-85 years old
Unmet criteria:
Previous history of allopurinol administration,
Cardiogenic shock,
Grade III-IV of pulmonary edema,
The diagnosis of ventricular tachycardia or ventricular fibrillation before the study
Intervention groups
The case group: treatment with loading dose of 600 mg allopurinol before angiography
The control group: treatment with placebo similar in shape, color, and size before angiography
Effect of high dose of Allopurinol loading on level of inflammatory markers and in hospital composite events in Non ST-segment elevation myocardial infarction patients who refer to chamran hospital in Esfahan city.
Public title
Effect of Allopurinol in treatment of patients with Non ST-segment elevation myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic type chest pain
Non ST-segment elevation
Positive troponin biomarker
Age of patient between 18-85
Exclusion criteria:
History of Allopurinol consumption
Cardiogenic shock
Pulmonary edema with functional class III orIV
Ventricular tachycardia or ventricular fibrillation
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the included patients will be provided a particular number allocated him/her to either treatment with allopurinol if the number is even or to placebo treatment if the number is odd.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is different from a person who provides the drugs to the patients, therefore the researcher is blinded to the type of medication.
Besides, the groups will be provided to the statistician in codes 1 and 2; therefore the statistician is blinded to the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-05, 1398/07/13
Ethics committee reference number
IR.mui.med.rec.1398.346
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction without ST segment elevation
ICD-10 code
I22
ICD-10 code description
Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Inflammatory markers including highly sensitive C-reactive protein and highly sensitive cardiac troponin
Timepoint
Before the angiography and within 24 hours after acute myocardial infarction
Method of measurement
Blood sampling and laboratory assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 600 mg loading dose of allopurinol before angiography
Category
Treatment - Drugs
2
Description
Control group: Treatment with placebo similar in shape, color and size before angiography
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Ali Asadi
Street address
Moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3260 0965
Email
asadiali.689@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9595
Email
mortazavi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
7Aqiq, Ghadir Ave., Sepahan Shahr, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3651 2852
Fax
Email
asadiali.689@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
7Aqiq, Ghadir Ave., Sepahan Shahr, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3651 2852
Fax
Email
asadiali.689@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
7Aqiq, Ghadir Ave., Sepahan Shahr, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3651 2852
Fax
Email
asadiali.689@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
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
the data of the current study are accessible in case of consent from the professor responsible for the study
When the data will become available and for how long
Following the publication of the manuscript the data are accessible
To whom data/document is available
The cardiologists who have similar proposal can access the data
Under which criteria data/document could be used
In cases of the consent from the professor responsible for the study and having related proposals
From where data/document is obtainable
To the professor responsible for the study
What processes are involved for a request to access data/document
An Email or telephoning to the professor responsible for the study