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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):

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

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University
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