Based on the antioxidant effect of omega-3 polyunsaturated fatty acids and the potential role of free radicals in the pathogenesis of contrast-induced nephropathy (CIN), in this study, we aimed to assess the effect of omega-3 in the prevention of CIN in patients undergoing percutaneous coronary intervention (PCI). Eighty patients candidate of elective PCI will be randomly assigned into two groups. Inclusion criteria are eGFR higher than 60 ml/min/1.73 m2, the ages of 18 to 80 years, and patients undergoing elective PCI. The patients treated with N-acetyl cysteine or receiving vitamin C before PCI will be excluded from the study. The intervention group will receive 2500 mg single dose of omega-3 plus standard preventive therapy of CIN (hydration) 12 hrs before PCI whereas the control group will just receive standard regimen. Only analysts are blinded in this study. Serum cystanin C and creatinine will be assessed before and 24 hrs after PCI as a primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041920441N4
Registration date:2016-05-31, 1395/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-31, 1395/03/11
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
2016-03-10, 1394/12/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Omega-3 in the prevention of contrast-induced nephropathy after percutaneous coronary intervention
Public title
The role of omega-3 polyunsaturated fatty acids in the prevention of contrast-induced nephropathy (CIN) in post percutaneous coronary intervention (PCI) patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included GFR more than 60 ml/min/1.73 m2; the ages of 18 to 80 years; patients undergoing elective PCI. Exclusion criteria: Pretreatment with N-acetyl cystein or intravenous vitamin C; sensitivity or tolerance to ASA or Clopidogrel or omega-3; 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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand avenue, ُShiraz, Iran
City
Shiraz
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.REC.1394.208
Health conditions studied
1
Description of health condition studied
Renal disease
ICD-10 code
N14.1
ICD-10 code description
Contrast-induced nephropathy
Primary outcomes
1
Description
Cystatin C
Timepoint
Baseline and 24 hours after PCI
Method of measurement
Kit
2
Description
Serum creatinine
Timepoint
Baseline and 24 hours after PCI
Method of measurement
Kit
Secondary outcomes
1
Description
Contrast-induced nephropathy occurrence
Timepoint
24 hrs after PCI
Method of measurement
Based on cystatin C
Intervention groups
1
Description
Intervention: administration of omega-3, 12hr before percutaneous coronary intervention plus standard contrast-induced nephropathy preventive therapy (hydration)
Category
Prevention
2
Description
Control: just standard contrast-induced nephropathy preventive therapy (hydration)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra heart center
Full name of responsible person
Farzaneh Foroughinia
Street address
Alzahra heart center, Sibooye avenue, Shiraz, Fars, Iran