Top

BMC Cardiovascular Disorders

Published in:

Open Access 01-12-2024 | Migraine | Study Protocol

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

Authors: Yang Zi-yang, Li Hezhi, Luo Dongling, Wang Ximeng, Zhang Caojin, for the SPRING Investigators

Published in: BMC Cardiovascular Disorders | Issue 1/2024

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).

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):1204–22.CrossRef

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.CrossRefPubMed

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.CrossRefPubMedPubMedCentral

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):516–24.CrossRefPubMed

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):242–53.CrossRefPubMed

Yan C, Li H, Wang C, Yu H, Guo T, Wan L, Yundan P, Wang L, Fang W. Frequency and size of in situ thrombus within patent foramen ovale. Stroke. 2023;54(5):1205–13.CrossRefPubMed

Dong B, Lu Y, He S, Li B, Li Y, Lai Q, Li W, Ji S, Chen Y, Dai L, Chen L. Multisite and multitimepoint proteomics reveal that patent foramen ovale closure improves migraine and epilepsy by reducing right‐to‐left shunt‐induced hypoxia. MedComm (2020). 2023;4(4):e334.

Guo ZN, Qu Y, Gao Y, Xing Y, Ma H, Liu J, Guo YZ, Chang J, Zhang P, Jin H, et al. Changes in cerebral autoregulation, stroke-related blood biomarkers, and autonomic regulation after patent foramen ovale closure in severe migraine patients. CNS Neurosci Ther. 2023;29(10):3031–42.CrossRefPubMedPubMedCentral

Khasiyev F, Arsava EM, Topcuoglu MA. Cerebral vasomotor reactivity in migraine: effect of patent foramen ovale and aerogenic microembolism. Neurol Res. 2020;42(9):795–804.CrossRefPubMed

10.

Zhao E, Xie H, Zhang Y. A nomogram for the prediction of cessation of migraine among patients with patent foramen ovale after percutaneous closure. Front Neurol. 2020;11:593074.CrossRefPubMedPubMedCentral

11.

Ben-Assa E, Rengifo-Moreno P, Al-Bawardy R, Kolte D, Cigarroa R, Cruz-Gonzalez I, Sakhuja R, Elmariah S, Pomerantsev E, Vaina LM, et al. Effect of residual interatrial shunt on migraine burden after transcatheter closure of patent foramen ovale. JACC Cardiovasc Interv. 2020;13(3):293–302.CrossRefPubMed

12.

Qi Y, Zhang Y, Luo X, Cheng G, Du Y, Liu R, Xie H, Cheng Y, Guo Y, Luo G. Efficacy of patent foramen ovale closure for treating migraine: a prospective follow-up study. J Investig Med. 2021;69(1):7–12.CrossRefPubMed

13.

He YD, Yan XL, Qin C, Zhang P, Guo ZN, Yang Y. Transcatheter patent foramen ovale closure is effective in alleviating migraine in a 5-year follow-up. Front Neurol. 2019;10:1224.CrossRefPubMedPubMedCentral

14.

Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. Percutaneous closure of patent foramen ovale in patients with migraine: the PREMIUM Trial. J Am Coll Cardiol. 2017;70(22):2766–74.CrossRefPubMed

15.

Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016;37(26):2029–36.CrossRefPubMed

16.

Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe SL, Rees T, De Giovanni JV, Morrison WL, et al. Migraine intervention with STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation. 2008;117(11):1397–404.CrossRefPubMed

17.

Rendas-Baum R, Yang M, Varon SF, Bloudek LM, DeGryse RE, Kosinski M. Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine. Health Qual Life Outcomes. 2014;12:117.CrossRefPubMedPubMedCentral

18.

Ware JE Jr., Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–483.

19.

Mojadidi MK, Kumar P, Mahmoud AN, Elgendy IY, Shapiro H, West B, Charles AC, Mattle HP, Sorensen S, Meier B, et al. Pooled analysis of PFO occluder device trials in patients with PFO and migraine. J Am Coll Cardiol. 2021;77(6):667–76.CrossRefPubMed

Title: 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
Authors: Yang Zi-yang
Li Hezhi
Luo Dongling
Wang Ximeng
Zhang Caojin
for the SPRING Investigators
Publication date: 01-12-2024
Publisher: BioMed Central
Keyword: Migraine
Published in: BMC Cardiovascular Disorders / Issue 1/2024
Electronic ISSN: 1471-2261
DOI: https://doi.org/10.1186/s12872-024-03866-3

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

Watch now

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Conclusion

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2024

Sutureless Biological Aortic Valve Replacement (Su-AVR) in Redo operations: a retrospective real-world experience report of clinical and echocardiographic outcomes

In emergency hypertension, could biomarkers change the guidelines?

Ac2-26 activated the AKT1/GSK3β pathway to reduce cerebral neurons pyroptosis and improve cerebral function in rats after cardiopulmonary bypass

Predictive value of the serum uric acid to high-density lipoprotein cholesterol ratio for culprit plaques in patients with acute coronary syndrome

Early changes in cardiac troponin T and NT-proBNP levels in neonates receiving ECMO support: a single-center experience

Prevalence and modifiable risk factors of cognitive frailty in patients with chronic heart failure in China: a cross-sectional study

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page