Unique ID issued by UMIN | UMIN000034171 |
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Receipt number | R000038952 |
Scientific Title | Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy |
Date of disclosure of the study information | 2018/09/17 |
Last modified on | 2018/09/16 20:18:48 |
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Japan |
Carotid artery stenosis
Neurosurgery |
Others
NO
We will administer EPA, which has an effect of inhibiting the progression of arteriosclerosis, to CEA patients, measure the EPA concentration in vascular tissues not reported in Japan, and compare with the usual treatment method to investigate the progress of arteriosclerosis.
Efficacy
Confirmatory
Pragmatic
Phase IV
1)Tissue fatty acid fraction
EPA / AA ratio, DHA / AA ratio
2)Tissue inflammatory cell evaluation
CD68
3)echo examination
Carotid echo
1)Blood data including blood lipids
TG, LDL-Chol, HDL-Chol, T-Chol, non-HDL-Chol, AST, ALT, ALP, total bilirubin, total protein, albumin, BUN, Cre, eGFR, Na, K, Cl
2)Blood fatty acid fraction
EPA / AA ratio, DHA / AA ratio
3)blood inflammation marker
hs-CRP
PTX 3
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Continuous treatment continued for a certain period of time Administration group to which EPA is not administered (40 cases).
EPA group (40 patients) who newly added 1800 mg / day of a high-purity EPA preparation (Epadel S) to the treatment that was being conducted until then.
20 | years-old | <= |
85 | years-old | > |
Male and Female
1. Carotid artery plaque has been confirmed, patients undergoing cerebral neurosurgery CEA
2. Patients who are taking statins diagnosed as dyslipidemia
3. Patients taking antiplatelet drugs
4. Patients aged between 20 and 85
1. Patients with a history of hypersensitivity to high-purity EPA preparations
2. Omega-3 fatty acid preparation (Rotriga)/Patient taking EPA preparation
3. Bleeding patients (hemophilia, capillary vulnerability, gastrointestinal bleeding, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage etc.)
4. People with peptic ulcer
5. Other patients who are considered inappropriate by the attending physician
80
1st name | |
Middle name | |
Last name | Takakazu Kawamata |
Tokyo Women's Medical University
Neurosurgery
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
tkawamata@twmu.ac.jp
1st name | |
Middle name | |
Last name | Tatsuya Ishikawa |
Tokyo Women's Medical University
Neurosurgery
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
tishikawa@twmu.ac.jp
Tokyo Women's Medical University
Tokyo Women's Medical University
Self funding
NO
東京女子医科大学病院
2018 | Year | 09 | Month | 17 | Day |
Unpublished
Completed
2016 | Year | 11 | Month | 27 | Day |
2016 | Year | 11 | Month | 27 | Day |
2017 | Year | 11 | Month | 27 | Day |
2018 | Year | 05 | Month | 27 | Day |
2018 | Year | 06 | Month | 27 | Day |
2018 | Year | 07 | Month | 27 | Day |
2018 | Year | 09 | Month | 16 | Day |
2018 | Year | 09 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038952
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