Effect of omega 3 on cardiac necrosis biomarkers, TnI and CK-MB, and 30-days major adverse cardiac effects (MACE) after percutaneous coronary intervention (PCI) in chronic kidney disease patients (CKD)
The aim of this study is to investigate the efficacy of omega 3 fatty acids in decreasing cardiac necrosis biomarkers, TnI and CK-MB, and major adverse cardiac effects after percutaneous coronary intervention in patients with chronic kidney disease. 80 patients with chronic kidney disease, who are candidate of elective percutaneous coronary intervention, will be included. Patients with these exclusion criteria will be excluded: performing Cronary Artery Bypass Graft during last 3 months, treatment with glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention, treatment with bivalirudine during percutaneous coronary intervention, sensitivity or tolerance to ASA or Clopidogrel, sever active bleeding. The intervention group will receive 3 gr single dose of omega 3 plus standard regimen before percutaneous coronary intervention (ASA, clopidogrel and heparin) whereas the control group just will receive standard regimen. TnI and CK-MB will be assessed before and 24 hrs after percutaneous coronary intervention as a primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040920441N2
Registration date:2015-04-12, 1394/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-12, 1394/01/23
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, International branch
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega 3 on cardiac necrosis biomarkers, TnI and CK-MB, and 30-days major adverse cardiac effects (MACE) after percutaneous coronary intervention (PCI) in chronic kidney disease patients (CKD)
Public title
Effect of omega 3 on cardiac necrosis biomarkers, TnI and CK-MB
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent form; NSTE-ACS candidate for elective PCI; treatment with ASA at least 5 days before PCI; CKD patients (GFR ˂ 60 ml/min) Exclusion criteria: CABG during last 3 months; treatment with glycoprotein IIb/IIIa inhibitors during PCI; treatment with bivalirudine during PCI; sensitivity or tolerance to ASA or Clopidogrel; unsatisfactory PCI; sever active bleeding; sever adverse effects to drugs
Age
From 18 years old to 80 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences, Deputy for research
Street address
Deputy for research, Central building of Shiraz University of Medical Sciences, Zand avenue
City
Shiraz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
CT-2015-231
Health conditions studied
1
Description of health condition studied
heart disease
ICD-10 code
I70
ICD-10 code description
Atherosclerosis
Primary outcomes
1
Description
Creatine kinase-MB
Timepoint
24 hours after PCI
Method of measurement
ELISA
2
Description
troponin I
Timepoint
24 hours after PCI
Method of measurement
ELISA
Secondary outcomes
1
Description
Major Adverse Cardiac Effect (MACE)
Timepoint
30 days after PCI
Method of measurement
Following patients by phone
Intervention groups
1
Description
Standard treatment before PCI (clopidogrel+heparin+ASA) plus 3gr single dose of omega 3 soft gel at least 12 hours before PCI
Category
N/A
2
Description
ُStandard drug treatment before PCI (clopidogrel+heparin+ASA)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Maryam Forouzmehr
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Kowsar heart center
Full name of responsible person
Maryam Forouzmehr
Street address
City
Shiraz
3
Recruitment center
Name of recruitment center
Alzahra heart center
Full name of responsible person
Maryam Forouzmehr
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, International branch
Full name of responsible person
Dr Farzaneh Foroughinia
Street address
Faculty of pharmacy, Shiraz University of Medical Sciences, Rokn Abad street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, International branch