To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study
IntroductionThe aim of this large, prospective, double-blind randomized controlled trial is to investigate the effect of atorvastatin on the formation of collateral blood vessels in patients after encephaloduroarteriosynangiosis (EDAS) and to provide a theoretical basis for clinical drug interventio...
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Frontiers Media S.A.
2023-06-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1169253/full |
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| author | Gan Gao Gan Gao Qian-Nan Wang Fang-Bin Hao Fang-Bin Hao Xiao-Peng Wang Xiao-Peng Wang Si-Meng Liu Si-Meng Liu Min-Jie Wang Min-Jie Wang Cong Han Xiang-Yang Bao Lian Duan |
| author_facet | Gan Gao Gan Gao Qian-Nan Wang Fang-Bin Hao Fang-Bin Hao Xiao-Peng Wang Xiao-Peng Wang Si-Meng Liu Si-Meng Liu Min-Jie Wang Min-Jie Wang Cong Han Xiang-Yang Bao Lian Duan |
| author_sort | Gan Gao |
| collection | DOAJ |
| description | IntroductionThe aim of this large, prospective, double-blind randomized controlled trial is to investigate the effect of atorvastatin on the formation of collateral blood vessels in patients after encephaloduroarteriosynangiosis (EDAS) and to provide a theoretical basis for clinical drug intervention. Specifically, we will determine whether atorvastatin has an effect on the development of collateral vascularization and on cerebral blood perfusion after revasculoplasty in patients with moyamoya disease (MMD).Methods and analysisOverall, 180 patients with moyamoya disease will be recruited and randomly assigned to the atorvastatin treatment group or the placebo control group in a 1:1 ratio. Before revascularization surgery, magnetic resonance imaging (MRI) scanning and digital subangiography (DSA) examination will be routinely performed on the enrolled patients. All patients will receive intervention via EDAS. According to the randomization results, patients in the experimental group will be treated with atorvastatin (20 mg/day, once a day, for 8 weeks) and patients in the control group will be treated with placebo (20 mg/day, once a day, for 8 weeks). All participants will return to the hospital for MRI scan and DSA examination 6 months after EDAS surgery. The primary outcome of this trial will be the difference in the formation of collateral blood vessels revealed by DSA examination at 6 months after EDAS surgery between the two groups. The secondary outcome will be an improvement in the dynamic susceptibility contrast sequence cerebral perfusion on MRI at 6 months after EDAS, compared to the preoperative baseline.Ethics and disseminationThis study was approved by the Ethics Committee of the First Medical Center of the PLA General Hospital. All participates will voluntary provide written informed consent before participating in the trial.Clinical trial registrationClinicalTrials.gov, ChiCTR2200064976. |
| first_indexed | 2024-03-13T08:07:52Z |
| format | Article |
| id | doaj.art-eca603ca6f4b484c89889f54a8bbcfec |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-03-13T08:07:52Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neurology |
| spelling | doaj.art-eca603ca6f4b484c89889f54a8bbcfec2023-06-01T04:20:07ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-06-011410.3389/fneur.2023.11692531169253To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled studyGan Gao0Gan Gao1Qian-Nan Wang2Fang-Bin Hao3Fang-Bin Hao4Xiao-Peng Wang5Xiao-Peng Wang6Si-Meng Liu7Si-Meng Liu8Min-Jie Wang9Min-Jie Wang10Cong Han11Xiang-Yang Bao12Lian Duan13Chinese PLA Medical School, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaChinese PLA Medical School, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaChinese PLA Medical School, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaChinese PLA Medical School, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaChinese PLA Medical School, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaDepartment of Neurosurgery, Chinese PLA General Hospital, Beijing, ChinaIntroductionThe aim of this large, prospective, double-blind randomized controlled trial is to investigate the effect of atorvastatin on the formation of collateral blood vessels in patients after encephaloduroarteriosynangiosis (EDAS) and to provide a theoretical basis for clinical drug intervention. Specifically, we will determine whether atorvastatin has an effect on the development of collateral vascularization and on cerebral blood perfusion after revasculoplasty in patients with moyamoya disease (MMD).Methods and analysisOverall, 180 patients with moyamoya disease will be recruited and randomly assigned to the atorvastatin treatment group or the placebo control group in a 1:1 ratio. Before revascularization surgery, magnetic resonance imaging (MRI) scanning and digital subangiography (DSA) examination will be routinely performed on the enrolled patients. All patients will receive intervention via EDAS. According to the randomization results, patients in the experimental group will be treated with atorvastatin (20 mg/day, once a day, for 8 weeks) and patients in the control group will be treated with placebo (20 mg/day, once a day, for 8 weeks). All participants will return to the hospital for MRI scan and DSA examination 6 months after EDAS surgery. The primary outcome of this trial will be the difference in the formation of collateral blood vessels revealed by DSA examination at 6 months after EDAS surgery between the two groups. The secondary outcome will be an improvement in the dynamic susceptibility contrast sequence cerebral perfusion on MRI at 6 months after EDAS, compared to the preoperative baseline.Ethics and disseminationThis study was approved by the Ethics Committee of the First Medical Center of the PLA General Hospital. All participates will voluntary provide written informed consent before participating in the trial.Clinical trial registrationClinicalTrials.gov, ChiCTR2200064976.https://www.frontiersin.org/articles/10.3389/fneur.2023.1169253/fullmoyamoya diseaseatorvastatinEDAScollateral circulationsurgery |
| spellingShingle | Gan Gao Gan Gao Qian-Nan Wang Fang-Bin Hao Fang-Bin Hao Xiao-Peng Wang Xiao-Peng Wang Si-Meng Liu Si-Meng Liu Min-Jie Wang Min-Jie Wang Cong Han Xiang-Yang Bao Lian Duan To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study Frontiers in Neurology moyamoya disease atorvastatin EDAS collateral circulation surgery |
| title | To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study |
| title_full | To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study |
| title_fullStr | To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study |
| title_full_unstemmed | To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study |
| title_short | To explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease: a prospective double-blind randomized controlled study |
| title_sort | to explore the effectiveness of atorvastatin in the postoperative formation of collateral blood vessels after encephaloduroarteriosynangiosis in patients with moyamoya disease a prospective double blind randomized controlled study |
| topic | moyamoya disease atorvastatin EDAS collateral circulation surgery |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1169253/full |
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