Effect of L-Carnitine on QT-Dispersion of patients with acute myocardial infarction in Rafsanjan Ali Ibn-Abitaleb Hospital: A randomized, double‐blind, placebo-controlled trial
Investigate the antioxidant effects of L-carnitine on QT-dispersion of patients with acute myocardial infarction hospitalized in Ali Ibn Abi Talib Hospital in Rafsanjan so that, if possible, the effect of this biological substance, even if possible these patients have a poor prognosis.
Design
Clinical trial with control group, double blind, randomized.
Settings and conduct
The ECG is taken from the patient on the first day and at the end of the 8th week, and QT-dispersion is calculated Oral L-carnitine tablets at a dose of 250 mg will be administered twice daily for 8 weeks.
Population: Patients admitted to CCU of Ali Ibn Abi Talib Hospital in Rafsanjan. In this study, the patient and the investigator were not informed about the type and method of administration of the drug in order to observe the details of the stud
Participants/Inclusion and exclusion criteria
Participants/Inclusion: Patients with Acute Myocardial Infarction Patients undergoing angiography have more than 80% coronary stenosis,The type and extent of MI and age restriction are not relevant in this study.
Participants/ exclusion: Moderate and severe valvular disease,
Pregnancy, Left and right bundle branch block, Patients taking vitamin supplements, Patients taking QT prolonging drugs Underlying diseases such as diabetes and liver failure and chronic renal failure grade 4 and 5.
Intervention groups
Intervention group: 60 patients with diagnosis of acute myocardial infarction (oral L-carnitine tablet at a dose of 250 mg twice daily for 8 weeks).
Control group: 60 patients with acute myocardial infarction (Placebo (starch tablets) are powdered in the same shells and will be prescribed twice daily for 8 weeks).
Effect of L-Carnitine on QT-Dispersion of patients with acute myocardial infarction in Rafsanjan Ali Ibn-Abitaleb Hospital: A randomized, double‐blind, placebo-controlled trial
Public title
Effect of L-Carnitine on QT-Dispersion of patients with acute myocardial infarction in Rafsanjan Ali Ibn-Abitaleb Hospital: A randomized, double‐blind, placebo-controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Acute Myocardial Infarction with History, Examination, ECG and Cardiac Enzymes and Angiography
Patients undergoing angiography have more than 80% coronary stenosis
The type and extent of MI and age restriction are not relevant in this study.
Exclusion criteria:
Moderate and severe valvular disease
Pregnancy
Left and right bundle branch block
Patients taking vitamin supplements
Patients taking QT prolonging drugs (amiodarone, sotalol, quinidine, azithromycin, clarithromycin, erythromycin)
Underlying diseases such as diabetes (due to the effect of diabetes-induced oxidative stress on the antioxidant effects of L-carnitine) and liver failure (due to hepatic drug metabolism), and chronic renal failure grade 4 and 5 (GFR <30 mL / min / 1.73)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple randomization
Unit of randomization: individual
Tools used in randomization: table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind randomized clinical trial. In this study, in order to observe the details of the double-blind study, the patient and the investigator are not informed of any type and method of administration, only the physician is aware of the type and method of administration of the drug and placebo, and how the study and control groups are divided.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsanjan University of Medical Sciences
Street address
َAli Ibn Abital Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2018-08-08, 1397/05/17
Ethics committee reference number
IR.RUMS.REC.1397.096
Health conditions studied
1
Description of health condition studied
Patients with acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
In the study "Effect of oral L-carnitine tablets on QT-dispersion in patients with acute myocardial infarction hospitalized at Ali Ibn Abi Talib Hospital in Rafsanjan" the primary outcome could be "reduced QT-dispersion".
Timepoint
In the study "Effect of oral L-carnitine tablets on QT-dispersion in patients with acute myocardial infarction hospitalized in Hazrat Ali Ibn Abi Talib Hospital in Rafsanjan" is the timing of measurement of QT-dispersion in the first day of study and last day.
Method of measurement
The Method of measurement: how to measure the outcome variable: QT-dispersion is calculated by measuring the difference between the largest and the smallest QT. Interval in 12-lead of Electrocardiogram.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:60 patients with acute myocardial infarction admitted to Ali Ibn Abi Talib Hospital in Rafsanjan. L-carnitine treatment group. (Oral L-carnitine tablets will be prescribed twice daily for up to 24 hours from hospitalization at a dose of 250 mg daily for 8 weeks).
Category
Prevention
2
Description
Control group: 60 patients with acute myocardial infarction admitted to Ali Ibn Abi Talib Hospital in Rafsanjan. Placebo (starch tablets) are milled and powdered in the same shells and are reheated twice daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital in Rafsanjan
Full name of responsible person
Fateme Askari Hosni
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Gholamreza Bazmandegan
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Askari Hosni
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Askari Hosni
Position
General Physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Askari Hosni
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
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
Not applicable
Informed Consent Form
No - There is not 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