The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).

Key facts

Study ID

NCT02096757

Run by

University of California, San Francisco

People needed

8

Starts

2014-06-01

Expected to finish

2017-03-01

Last updated by the study team

2020-09-18

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)
• Objective evidence of PAD e.g. ABI < 0.9, TBI < 0.6 or absent pedal pulses
• Currently not taking high-dose n-3 PUFA, as defined by >2 g/day
• Able to provide written informed consent AND
• Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.

You may not qualify if…

• Age < 40 or > 90 years
• Undergoing open surgical revascularization
• Evidence of active infection in limb or foot or osteomyelitis
• Extensive tissue loss (Rutherford Class VI Disease)
• Diagnosed hypercoagulable state
• Non-atherosclerotic/aneurysmal disease as indication for procedure
• Chronic liver disease or myopathy
• End-stage renal disease (CKD 5)
• Poorly controlled diabetes (HbA1C > 8%)
• Recent other major surgery or illness within 6 weeks
• Use of immunosuppressives or chronic inflammatory disorders
• History of organ transplantation
• Pregnancy or plans to become pregnant
• Condition in which patient life expectancy is less than one year

Where it is running

• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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