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Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)

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ClinicalTrials.gov Identifier: NCT01521845
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : July 9, 2012
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Jamshid Salamzadeh, PhD, Shahid Beheshti University of Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Coronary Arteriosclerosis
Intervention Drug: omega 3
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega 3 Control
Hide Arm/Group Description receive omega 3 in addition to standard treatment This group is without omega 3 : just receives standard treatment
Period Title: Overall Study
Started 52 52
Completed 43 47
Not Completed 9 5
Arm/Group Title Omega 3 Control Total
Hide Arm/Group Description receive omega 3 in addition to standard treatment This group is without omega 3 : just receives standard treatment Total of all reporting groups
Overall Number of Baseline Participants 43 47 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 47 participants 90 participants
62  (11) 60  (11) 61  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 47 participants 90 participants
Female
16
  37.2%
14
  29.8%
30
  33.3%
Male
27
  62.8%
33
  70.2%
60
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 43 participants 47 participants 90 participants
43 47 90
1.Primary Outcome
Title Cardiac Necrosis Biomarkers (CKMB, Troponin I)
Hide Description difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Time Frame 8 and 24 hrs after percutaneous coronary intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Control
Hide Arm/Group Description:
receive omega 3 in addition to standard treatment
This group is without omega 3 : just receives standard treatment
Overall Number of Participants Analyzed 43 47
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
13
(10 to 18)
18
(13 to 23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega 3, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Inflammation Marker (CRP)
Hide Description difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Time Frame 8 and 24 hrs after percutaneous coronary intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Control
Hide Arm/Group Description:
receive omega 3 in addition to standard treatment
This group is without omega 3 : just receives standard treatment
Overall Number of Participants Analyzed 43 47
Median (Inter-Quartile Range)
Unit of Measure: mg/l
3
(1 to 10)
6
(2 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega 3, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Control
Hide Arm/Group Description:
receive omega 3 in addition to standard treatment
This group is without omega 3 : just receives standard treatment
Overall Number of Participants Analyzed 43 47
Measure Type: Number
Unit of Measure: participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega 3, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method not comparable
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega 3 Control
Hide Arm/Group Description receive omega 3 in addition to standard treatment This group is without omega 3 : just receives standard treatment
All-Cause Mortality
Omega 3 Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Omega 3 Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Omega 3 Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/47 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Jamshid Salamzadeh
Organization: Shaheed Beheshti Medical University
Phone: 00982188662334
Responsible Party: Jamshid Salamzadeh, PhD, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01521845     History of Changes
Other Study ID Numbers: 90-1-94-8048
First Submitted: January 19, 2012
First Posted: January 31, 2012
Results First Submitted: May 31, 2012
Results First Posted: July 9, 2012
Last Update Posted: December 10, 2012