Double blinded clinical trial on the effect of Q10 supplement on the level of CK-MB and Troponine enzymes in patients undergoing Coronary Artery Bypass Graft (CABG) surgery
The aim of this Double-Blind randomized clinical trial study is the evaluation of the effect of Q10 supplementation on cardiac bio-markers (CKMB, CTnT) in patients undergoing CABG (Coronary Artery Bypass Graft). All patients with coronary heart disease referring for elective CABG are included. After signing an informed consent, all 80 patients will be divided into the two groups: 40 patients receiving Q10 (intervention group) and 40 patients receiving placebo (control group). Exclusion criteria include elevated CK-MB and cTnI and renal dysfunction (creatinine above 1.5 mg/dl). The intervention group will receive the Q10 supplement 150 mg a day (three 50- milligram capsule) for 7 days before surgery. The control group receive same capsule .The patients and medical personnel will not aware of the type of capsule give to the subject. Only the researcher will be aware of the code written on the boxes of the tablets. Inter and intra group blood levels of the cardiac bio-markers before and after the CABG will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122815957N1
Registration date:2014-09-22, 1393/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-22, 1393/06/31
Registrant information
Name
Jalal Moloudi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2536
Email address
j-moludi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blinded clinical trial on the effect of Q10 supplement on the level of CK-MB and Troponine enzymes in patients undergoing Coronary Artery Bypass Graft (CABG) surgery
Public title
Effect of Q10 supplementation on cardiovascular bio markers in patients undergoing open heart surgery. "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 80 patients' eligible for CABG surgery; Tehran Heart Hospital Rajai
Exclusion criteria: Patients with the following conditions (recent intake of antioxidants either warfarin. (a month) ; Valve replacement; and those with BMI above 30; Kidney disease (cr above 1.5)
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
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
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
2
Registry name
/
Secondary trial Id
/
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
0098
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
93-01-161-25555-115651
Health conditions studied
1
Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
(I21-I22)
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
level of Troponin
Timepoint
Pre-intervention and post-intervention and 24-hour, seven days after surgery.
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Levels of CK-MB
Timepoint
Pre-intervention and post-intervention and 24-hour, seven days after surgery.
Method of measurement
ELISA Kits
Intervention groups
1
Description
Intervention group: 150 mg Q10 supplementation will give to individuals in three divided doses (Q10 in capsule form -Iran Drug maker Exir Pharmaceuticals) for 7 days
Category
Other
2
Description
Control group: The control group will receive capsules with the same shape, from the same company with no therapeutic content (just the color) ,three times a day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Cardiovascular Hospital, Tehran
Full name of responsible person
Jalal Moludi
Street address
Rajai Cardiovascular Hospital, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesyan
Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
93-01-161-25555-116437
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
Department of Clinical Nutrition, School of Nutrition and Dietitics, Tehran University of Medical Sc
Full name of responsible person
Jalal Moludi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
0098
Phone
+98 21 8897 4463
Fax
+98 21 8897 4463
Email
J-MOLUDI@RAZI.TUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Dietitics, Tehran University of Medical Sc
Full name of responsible person
Jalal Moludi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
No. 20, Hojat doost St, Keshavarz Blv, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
00982188974463
Phone
+98 21 8897 4463
Fax
+98 21 8897 4463
Email
J-MOLUDI@RAZI.TUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Dietitics, Tehran University of Medical Sc
Full name of responsible person
Jalal Moludi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
No. 20, Hojat doost St, Keshavarz Blv, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
00982188974463
Phone
+98 939 951 6760
Fax
+98 21 8897 4463
Email
J-MOLUDI@RAZI.TUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)