The Effect of High dose of Allopurinol loading on Percutaneous Coronary Intervention Outcomes and In-hospital Clinical Results in ST-segment Elevation Myocardial Infarction Patients; A Double-blind Randomized Clinical Trial
- To determine and compare coronary blood flow after high dose allopurinol loading in ST elevation myocardial infarction patients undergoing primary precancerous coronary intervention
Design
Two arm randomized parallel groups, double blind with control group
Settings and conduct
80 STEMI patients that candidate for primary or rescue PCI are selected according to the inclusion criteria and randomized to two equal groups by computerized method. In the case group, 600 mg of Allopurinol received before the intervention and the control group received placebo medication. After PCI, its results interpreted based on TIMI flow and MBG. Patients were also followed up during hospitalization for MACE and complications. intervening / interpreter and analyzer are blinded.
Participants/Inclusion and exclusion criteria
Entry: Acute STEMI below 24 hours for primary or rescue PCI
No entry: Routine PCI, STEMI over 24 hours, Previous consumption of Allopurinol or other anti-inflammatory drugs, Cardiac shock, Pulmonary edema with NYHA class 3/4, Any electrical and mechanical complications of STEMI
Intervention groups
Case group: 600 mg oral dose of Allopurinol before the intervention and immediately after arrival to emergency ward
Control group: placebo similar in shape and size with intervention group medication
Main outcome variables
Prescribing a loading dose of Allopurinol before the PCI can be used clinically and practically to achieve better PCI results in STEMI patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181228042155N1
Registration date:2019-07-13, 1398/04/22
Registration timing:registered_while_recruiting
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Mohammad Kermani-Alghoraishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 9614
Email address
sm.kermani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High dose of Allopurinol loading on Percutaneous Coronary Intervention Outcomes and In-hospital Clinical Results in ST-segment Elevation Myocardial Infarction Patients; A Double-blind Randomized Clinical Trial
Public title
The Effect of Allopurinol on Percutaneous Coronary Intervention Outcomes in ST-segment Elevation Myocardial Infarction Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Acute ST-segment elevation MI
Symptom onset below 24 hours
PCI as primary or rescue approach
Exclusion criteria:
Acute STEMI onset more than 24 hours
Candide for routine PCI
Previous consumption pf Allopurinol and other anti-inflammatory medications
Cardiac shock
Pulmonary edema with NYHA class 3/4
Mechanical complications of acute STEMI
Electrical complication of acute STEMI
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in simple way by computer. In fact, each patient's code is divided into a group at the beginning of the emergency ward by the computer.
Blinding (investigator's opinion)
Double blinded
Blinding description
- The physician conducting the intervention and interpreting the results of the PCI as well as the patient who follow-up patients during the hospitalization period are blind to the case and control groups.
- The data analyzer is also blind to the groups.
Placebo
Used
Assignment
Parallel
Other design features
The first study to examine the effect of َpre-intervention Allopurinol administration on PCI results in STEMI patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.MUI.MED.REC.1398.138
Health conditions studied
1
Description of health condition studied
Precancerous Coronary Intervention Outcome
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Coronary flow according to Thrombolysis In Myocardial Infarction (TIMI flow)
Timepoint
After precancerous coronary intervention
Method of measurement
Angioplasty videos interpretation
2
Description
Coronary flow according to Myocardial blush grade (MBG)
Timepoint
After precancerous coronary intervention
Method of measurement
Angioplasty videos interpretation
Secondary outcomes
1
Description
Post MI Electrical and Mechanical complication
Timepoint
During hospitalization
Method of measurement
Electrocardiography and Echocardiography
2
Description
Major Adverse Cardiac Events (MACE)
Timepoint
During hospitalization
Method of measurement
Questionnaire and physician interpretation
3
Description
Troponin level
Timepoint
Admission time and 48 hour after it
Method of measurement
Laboratory kit
4
Description
ECG changes
Timepoint
Admission time and after precancerous coronary intervention
Method of measurement
Objective interpretation
Intervention groups
1
Description
Intervention group: Received 600 mg Allopurinol loading before precancerous coronary intervention followed by 100 mg daily up to admission, Jalinous pharmaceutical Co.
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Heart Center
Full name of responsible person
Mohammad Kermani-Alghoraishi
Street address
Salman Farsi St., Shahid Chamran Heart Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Fax
+98 31 3261 1405
Email
sm.kermani@med.mui.ac.ir
Web page address
https://chamran.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjooy Javanmard
Street address
Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sm.kermani@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
Mohammad Kermani-Alghoraishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St., Shahid Chamran Heart Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kermani-Alghoraishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St., Shahid Chamran Heart Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Keramni-Alghoraishi
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St., Shahid Chamran Heart Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patients data (Unidentifiable), Study protocol, Consent form, Clinical report will be reported in final paper
When the data will become available and for how long
Approximately 1 year after article printing
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In order to complete further studies in this field
From where data/document is obtainable
Contact by email and phone with Dr. Mohammad Kermani-Alghoraishi
sm.kermani@med.mui.ac.ir
0098 9133037414
What processes are involved for a request to access data/document
The data is available about 1 year after the publication of the article in the scope mentioned above in order to complete further studies.