Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2024 Apr 5;24(1):198.
doi: 10.1186/s12872-024-03866-3.

Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail

Yang Zi-Yang  1   2 , Li Hezhi  1 , Luo Dongling  1 , Wang Ximeng  3 , Zhang Caojin  4   5 ; SPRING Investigators
Collaborators, Affiliations
Multicenter Study

Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail

Yang Zi-Yang et al. BMC Cardiovasc Disord. .

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).

Keywords: Migraine; Patent foramen ovale; Randomized clinical trial.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study design. This figure explains the flow chart of the inclusion criteria screening and randomization
See this image and copyright information in PMC

References

    1. Diseases GBD, Injuries C. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–1222. doi: 10.1016/S0140-6736(20)30925-9. - DOI - PMC - PubMed
    1. Takagi H, Umemoto T, Group A A meta-analysis of case-control studies of the association of migraine and patent foramen ovale. J Cardiol. 2016;67(6):493–503. doi: 10.1016/j.jjcc.2015.09.016. - DOI - PubMed
    1. Tang Y, Peng A, Peng B, He S, Zhao X, Zhu Y, Lai W, Song T, Chen L. Association between patent foramen ovale and migraine without aura: a community-based cross-sectional study in China. BMJ Open. 2022;12(3):e056937. doi: 10.1136/bmjopen-2021-056937. - DOI - PMC - PubMed
    1. De Giuli V, Grassi M, Locatelli M, Gamba M, Morotti A, Bonacina S, Mazzoleni V, Pezzini D, Magoni M, Monastero R, et al. Cardiac sources of cerebral embolism in people with migraine. Eur J Neurol. 2021;28(2):516–524. doi: 10.1111/ene.14556. - DOI - PubMed
    1. Martinez-Majander N, Artto V, Ylikotila P, von Sarnowski B, Waje-Andreassen U, Yesilot N, Zedde M, Huhtakangas J, Numminen H, Jakala P, et al. Association between Migraine and Cryptogenic Ischemic Stroke in Young Adults. Ann Neurol. 2021;89(2):242–253. doi: 10.1002/ana.25937. - DOI - PubMed

Publication types

MeSH terms

Associated data