Author:
Zi-yang Yang,Hezhi Li,Dongling Luo,Ximeng Wang,Caojin Zhang, ,Weibin Chen,Tao Guo,Tongtao Cui,Zhanhang Wang,Zhaojun Xiong,Hanhua Gao,Junxing Lai,Jie Yuan,Jianying Chen,Xiaodong Wang,Wei Liu,Hongwei Zhang,Gangcheng Zhang,Xuan Zheng,Qunshan Shen,Xiaobin Chen,Dujiang Xie,Wenqi Zhang,Zhongchao Wang,Wenbin Wei,Yang Zhou,Wei Zhang
Abstract
Abstract
Background
Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates.
Methods
The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements.
Conclusion
The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).
Funder
Chinese Society of Cardiology
Publisher
Springer Science and Business Media LLC