A Randomized trial of Co-Enzyme Q10 on Plasma Level of Cardiac Troponin-I and Creatinine Kinase- MB in patients undergoing to angioplasty and stenting.
Objective: This study will be performed to evaluate the effect of Co-Enzyme Q10 in cardiac pre-procedural injury in patients undergoing angioplasty and stenting. Design: This is a prospective, randomized; controlled trial will perform on ischemic heart diseases patients undergoing angioplasty and stent insertion. Setting and conduct: All patients with ischemic heart diseases patients who undergoing angioplasty in Shahid Madani Hospital were randomized using permuted block randomization in two groups of Co-Enzyme Q10 treated and control. Participants: All consented patients with ischemic heart diseases aged 18-80 and undergoing of angioplasty and stent insertion will be entered. Exclusion Criteria will include elevation of CK-MB and cTnI 48 hours before PCI; history of CABG during last three months, history of previous MI; Renal dysfunction (creatinine above 2.5 mg/dl); unsuccessful PCI; Acute MI; cardiogenic shock; dialysis; Pregnancy; inability in filling and understanding of the consent form; unconsented patients; patients who want to discontinue the study at any time. Intervention: In Co-Enzyme Q10 group, all patients will receive totally 300 mg Co-Enzyme Q10 before PCI. In the control group, Co-Enzyme Q10 will not be administrated. Primary outcomes include comparison of blood level of CK-MB and cTnI 12 hours before and 8 and 24 hours after PCI in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311278307N3
Registration date:2014-02-19, 1392/11/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-19, 1392/11/30
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancelor for Research, Tabriz University Medical Sciences.
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized trial of Co-Enzyme Q10 on Plasma Level of Cardiac Troponin-I and Creatinine Kinase- MB in patients undergoing to angioplasty and stenting.
Public title
Evaluation of Co-Enzyme Q10 in cardiac pre-procedural injury of ischemic heart diseases patients undergoing angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ischemic heart diseases patients; Aged 18-80; undergoing of angioplasty; stent insertion; filling of consent form.
Exclusion Criteria: elevation of CK-MB and cTnI 48 hours before PCI; history of CABG during last three months, history of previous MI; Renal dysfunction (creatinine above 2.5 mg/dl); unsuccessful PCI; Acute MI; cardiogenic shock; dialysis; Pregnancy; inability in filling and understanding of the consent form; unconsented patients; patients who want to discontinue the study at any time.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization was performed using permuted block randomization with a block size of 2 and an allocation ratio of 1:1 in two groups of Pentoxifylline and control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Univrsity of Medical Sciences. Ethics committee.
Street address
Daneshghah Street
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
92133
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
CK-MB level
Timepoint
12 hours before and 8 and 24 hours after angioplasty
Method of measurement
ELISA kits
2
Description
cTnI level
Timepoint
12 hours before and 8 and 24 hours after angioplasty
Method of measurement
ELISA kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: In Co-Enzyme Q10 group, all patients will receive totally 300 mg Co-Enzyme Q10 before PCI.
Category
Treatment - Drugs
2
Description
Control: In the control group, Co-Enzyme Q10 will not be administrated. two groups will be given standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Dr.Taher Entezari Maleki
Street address
Daneshghah Street, Shahid Madani Heart Center
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Daneshghah street
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Universty of Medical Scienses.
Full name of responsible person
Dr. Taher Entezari-Maleki
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Daneshghah Street-faculty of pharmacy
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
+98 41 1334 4798
Email
tentezari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Taher Entezari-Maleki
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Daneshghah Street, Faculty of Pharmacy
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
+98 41 1334 4798
Email
tentezari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)