Protocol summary
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Study aim
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Evaluation of the effect of metformin on cardiac troponin-I in STEMI patients treated with thrombolytic therapy
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Design
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Randomized Control Trials, Double blind
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Settings and conduct
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This is a prospective, randomized controlled trial on a total of 80 consented patients older than 18 years with thrombolytic therapy who attended the Shahid Madani clinic of Tabriz University of Medical Science.intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.The blood level of cTnI will be checkedevery 8 hours for 48_72 hours in two groups with and without metformin.
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Participants/Inclusion and exclusion criteria
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Inclusion:Ischemic heart diseases ; age 18-80; undergoing of thrombolytic therapy; filling of consent form Exclusion:Elevation of troponin I- (above normal) at least 48 hours before thrombolytic therapy; history of CABG during last three months; history of previous MI; renal failure (creatinine clearance below 30 mg / dl or creatinine above 1 /4 in women and 1/5 in men);sensitivity to aspirin or clopidogrel and retaplase; cardiogenic shock; history of end-stage renal failure or dialysis; presence of metformin inhibition
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Intervention groups
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intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.
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Main outcome variables
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Comparison of cTnI enzyme levels in STEMI patients in the two groups studied.
General information
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Reason for update
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The number of people decreased due to Corona virus.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20111206008307N34
Registration date:
2020-06-02, 1399/03/13
Registration timing:
registered_while_recruiting
Last update:
2021-01-18, 1399/10/29
Update count:
1
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Registration date
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2020-06-02, 1399/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-05, 1398/10/15
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Expected recruitment end date
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2020-09-19, 1399/06/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of metformin on cardiac troponin-I in STEMI patients treated with thrombolytic therapy
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Public title
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Evaluation of the effect of metformin in STEMI patients treated with thrombolytic therapy
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ischemic heart diseases
age 18-80
undergoing of thrombolytic therapy
filling of consent form
Exclusion criteria:
Elevation of troponin I- (above normal) at least 48 hours before thrombolytic therapy
history of CABG during last three months
history of previous MI; renal failure (creatinine clearance below 30 mg / dl or creatinine above 1 /4 in women and 1/5 in men)
sensitivity to aspirin or clopidogrel and retaplase
cardiogenic shock; history of end-stage renal failure or dialysis
presence of metformin inhibition
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was done using computer generated random number (systematic randomization) by online Graphpad software by determining 2 study groups and 40 patients in each group (Control and Intervention) by an independent person.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-13, 1398/07/21
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Ethics committee reference number
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IR.TBZMED.REC.1398.713
Health conditions studied
1
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Description of health condition studied
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Ischemic heart diseases patients
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ICD-10 code
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I20, I21,
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ICD-10 code description
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ischemic heart diseases
Primary outcomes
1
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Description
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cTnI level
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Timepoint
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BASELINE،8،16، 24 AND 32 HOURS AFTER Thrombolytic
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: intervention group will recieve 1000 mg of metformin before thrombolytic with standard treatments
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Category
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Treatment - Drugs
2
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Description
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Control group:Control group will only recieve standard treatments
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All of the data of an article can be published after making patients unrecognized
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When the data will become available and for how long
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After publishing of article until 6 months after publishing of the results
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To whom data/document is available
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Data will be available to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims
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From where data/document is obtainable
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Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki
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What processes are involved for a request to access data/document
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After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission data will be send to applicants
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Comments
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