Evaluating the effect of L Carnitine administration on post percutaneous coronary intervention levels of Troponin I as a myocardial damage and high-sensitive C-Reactive Proteins as an Inflammatory markers
The goal of this randomized clinical trial is to evaluate the effect of L-Carnitine on post PCI biomarkers of myocardial damage and Inflammation in patients undergoing elective Percutaneous Coronary Intervention(PCI). Elevated cardiac enzymes indicating myocyte damage and increased levels of CRP as inflammatory marker occurs even after elective PCI had a direct correlation with In-stent restenosis and associated with increased risk of cardiac events during follow-up. Stent placement in the coronary arteries leading to increased intimal cell proliferation and extracellular matrix production is increased in inflammatory processes. Intra-coronary stents has revolutionized interventional cardiology but continued stenosis and atherosclerosis after it is still present as a serious concern. The surgical/anesthesia trauma caused the production of reactive oxygen species. Antioxidants can prevent activation of platelets in the oxidative stress caused by free radicals. L-Carnitine decreases atherosclerosis plaques by antioxidant effects and improves cholesterol metabolism. Its positive effects in patients with chronic heart failure ˛peripheral and coronary artery disease and also myocardial infarction was due to an increase in the mechanical strength of the heart, reduce in arrhythmia, decrease in cardiac remodeling and prevention of tissue necrosis. L - Carnitine treatment has also been shown to be capable of decreasing serum cholesterol and triglycerides. In this study 100 patients were randomly placed in two groups of 50 people. In the first group of patients, at the day before catheterization 3 g L - carnitine (1 g every 8 hours) is given and lasts for up to 48 hour later. The next group will not receive the drug. In both groups, blood samples are collected and level of high sensitive C-Reactive Protein (hs-CRP) and Troponin I (TnI) at baseline ¸24 and 48 hour after catheterization will be measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302088698N10
Registration date:2013-03-08, 1391/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-08, 1391/12/18
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of L Carnitine administration on post percutaneous coronary intervention levels of Troponin I as a myocardial damage and high-sensitive C-Reactive Proteins as an Inflammatory markers
Public title
Impact of l-carnitine on levels of myocardial damage and inflammation biomarkers after percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with ischemic heart disease that have more than 50 percent occlusion in angiography findings and candidates for elective Pecrcutaneous Coronary Intevention.Exclusion criteria: cardiogenic shock;ST Elevation Myocardial Infarction;pregnant and lactating womens;patients under 18 years;immunologic or hematologic disorders;current infection;chronic kidney disease;serum creatinine above 2.5 mg/dl;hypothyroidism;epilepsy or convulsion;chronic liver disease;cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
16 Azar St., Qhods St., Tehran University of Medical Sciences
City
tehran
Postal code
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
19354
Health conditions studied
1
Description of health condition studied
ischemic heart disease
ICD-10 code
I20-I25
ICD-10 code description
Myocardial ischemia followed by decreased oxygen to the myocardium
Primary outcomes
1
Description
high sensitive C--Reactive protein
Timepoint
baseline¸24 and 48 hours after
Method of measurement
Elisa kit
2
Description
troponin I
Timepoint
baseline¸24 and 48 hours after
Method of measurement
Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
In the first group of patients, at 24 hour before catheterization 3 g L - carnitine (1 g every 8 hours) is given and lasts for up to 48 hour later. blood samples at baseline ¸24 and 48 hour after catheterization are collected and level of high sensitive C-Reactive Protein (hs-CRP) and Troponin I (TnI) will be measured
Category
Treatment - Drugs
2
Description
Medication will not be given to patients in the control group. Patients blood sample is collected at baseline and 24 hour after catheterization.Patients blood sample is collected at baseline ¸24 and 48 hour after catheterization and levels ofCRP and TnI will be measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mohammad Alidousti
Street address
North Kargar St., Jalal Al Ahmand St
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms. Fatemeh Saeedi
Street address
16 Azar St., Qhods St, Tehran University of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Assistant Professor
Other areas of specialty/work
Street address
16 Azar St., School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz,Mohammad Alidousti
Position
assistant professor-associated professor
Other areas of specialty/work
Street address
16 Azar St., School of Pharmacy, Tehran University of Medical Sciences
City
tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Ariamanesh
Position
Resident of Cardiology
Other areas of specialty/work
Street address
North Kargar, Jalale Ale Ahmad St., Tehran Heart Center
City
Tehran
Postal code
Phone
+880 2960050
Fax
Email
atefeh.ariamanesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)