Trial Outcomes & Findings for 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) (NCT NCT01521845)

NCT ID: NCT01521845

Last Updated: 2012-12-10

Results Overview

difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 104 participants
• Primary outcome timeframe: 8 and 24 hrs after percutaneous coronary intervention
• Results posted on: 2012-12-10

Participant Flow

Participant milestones

Measure	Omega 3 receive omega 3 in addition to standard treatment	Control This group is without omega 3 : just receives standard treatment
Overall Study STARTED	52	52
Overall Study COMPLETED	43	47
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Measure	Omega 3 n=43 Participants receive omega 3 in addition to standard treatment	Control n=47 Participants This group is without omega 3 : just receives standard treatment	Total n=90 Participants Total of all reporting groups
Age Continuous	62 years STANDARD_DEVIATION 11 • n=93 Participants	60 years STANDARD_DEVIATION 11 • n=4 Participants	61 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	33 Participants n=4 Participants	60 Participants n=27 Participants
Region of Enrollment Iran, Islamic Republic of	43 participants n=93 Participants	47 participants n=4 Participants	90 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 and 24 hrs after percutaneous coronary intervention

difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention

Outcome measures

Measure	Omega 3 n=43 Participants receive omega 3 in addition to standard treatment	Control n=47 Participants This group is without omega 3 : just receives standard treatment
Cardiac Necrosis Biomarkers (CKMB, Troponin I)	13 ng/ml Interval 10.0 to 18.0	18 ng/ml Interval 13.0 to 23.0

PRIMARY outcome

Timeframe: 8 and 24 hrs after percutaneous coronary intervention

difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention

Outcome measures

Measure	Omega 3 n=43 Participants receive omega 3 in addition to standard treatment	Control n=47 Participants This group is without omega 3 : just receives standard treatment
Inflammation Marker (CRP)	3 mg/l Interval 1.0 to 10.0	6 mg/l Interval 2.0 to 15.0

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Omega 3 n=43 Participants receive omega 3 in addition to standard treatment	Control n=47 Participants This group is without omega 3 : just receives standard treatment
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death	0 participants	0 participants

Adverse Events

Omega 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Jamshid Salamzadeh

Shaheed Beheshti Medical University

Phone: 00982188662334

Email: j.salamzadeh@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place