The goal of this randomized clinical trial is evaluation of impact of l-carnitine on biomarkers of platelet activation in patients undergoing elective Percutaneous Coronary Intervention(PCI). The main problem of coronary angioplasty is restenosis and acute occlusion. Restenosis after percutaneous transluminal coronary angioplasty (PTCA) is occured secondary to an overreaction of normal processes by the inherent inflammatory response to the mechanical traumatic tension of the arterial wall.L-carnitine decrease activation of NADPH oxidase via inhibition of arachidonic acid. NADPH oxidase is a platelet-activating enzyme. Due to increased oxidative stress and activation of platelets by several mediators and subsequently restenosis after coronary angioplasty, it is assumed that L - carnitine can help prevent this process.Patients with ischemic heart disease that have more than 50 percent occlusion in angiography findings and candidates for elective Pecrcutaneous Coronary Intevention are included and patients with ST Elevation Myocardial Infarction or under 18 years and others complications such as cancer or renal and hepatic dysfunctions are excluded from the study. 80 patients were randomly placed in two groups of 40 people (intervention and control group). The first group of patients, 3 g L - carnitine (1 g every 8 hours) is given at 1 day before catheterization and lasts for up to 24 hour after it. The next group will not receive the drug. In both groups, blood samples are collected and biomarkers of platelet activation such as CD40L, P-selectin and TGF-β at baseline and 24 hour after catheterization will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212178698N4
Registration date:2013-01-10, 1391/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-10, 1391/10/21
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 Medival Siences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of L-carnitine on biomarkers of platelet activation in patients undergoing elective Percutaneous Coronary Intervention(PCI)
Public title
Impact of l-carnitine in percutaneous coronary intervention
Purpose
Prevention
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 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
transforming growth factor beta(TGF-β)
Timepoint
baseline and 24 hour after
Method of measurement
Elisa kit
2
Description
CD40L
Timepoint
baseline and 24 hour after
Method of measurement
Elisa kit
3
Description
P-Selectin
Timepoint
baseline and 24 hour after
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Major adverse cardiac events)MACE)
Timepoint
1 month later
Method of measurement
evaluation of patient condition such as death, stent thrombosis confirmed by angiography ˛ acute coronary syndrome defined by AHA ˛ again revascularization with angioplasty or bypass
Intervention groups
1
Description
3 gram L - carnitine is administrated to intervention patients one day before catheterization (1 g every 8 hours) and lasts for up to 24 hour after it (for two days). Patients blood sample is collected at baseline and 24 hour after catheterization and biomarkers of platelet activation such as CD40L, P-selectin and TGF-β 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.
Category
Other
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, Kheirollah Gholami
Position
Assistant Professor, Professor
Other areas of specialty/work
Street address
16 Azar St., School of Pharmacy, Tehran University of Medical Sciences