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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01521845
First received: January 19, 2012
Last updated: December 6, 2012
Last verified: December 2012
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Coronary Arteriosclerosis
Intervention: Drug: omega 3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Omega 3 receive omega 3 in addition to standard treatment
Control This group is without omega 3 : just receives standard treatment

Participant Flow:   Overall Study
    Omega 3     Control  
STARTED     52     52  
COMPLETED     43     47  
NOT COMPLETED     9     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Omega 3 receive omega 3 in addition to standard treatment
Control This group is without omega 3 : just receives standard treatment
Total Total of all reporting groups

Baseline Measures
    Omega 3     Control     Total  
Number of Participants  
[units: participants]
  43     47     90  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 11     60  ± 11     61  ± 11  
Gender  
[units: participants]
     
Female     16     14     30  
Male     27     33     60  
Region of Enrollment  
[units: participants]
     
Iran, Islamic Republic of     43     47     90  



  Outcome Measures
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1.  Primary:   Cardiac Necrosis Biomarkers (CKMB, Troponin I)   [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ]

2.  Primary:   Inflammation Marker (CRP)   [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ]

3.  Secondary:   MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: j.salamzadeh@yahoo.com


No publications provided by Shahid Beheshti Medical University

Publications automatically indexed to this study:

Responsible Party: Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01521845     History of Changes
Other Study ID Numbers: 90-1-94-8048
Study First Received: January 19, 2012
Results First Received: May 31, 2012
Last Updated: December 6, 2012
Health Authority: Iran: Ethics Committee