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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.
Zi-Yang, Yang; Hezhi, Li; Dongling, Luo; Ximeng, Wang; Caojin, Zhang.
Afiliación
  • Zi-Yang Y; Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Zhong Shan Er Road No. 106, Yue Xiu District, Guangzhou, Guangdong, 510080, China.
  • Hezhi L; Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, Guangdong, China.
  • Dongling L; Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Zhong Shan Er Road No. 106, Yue Xiu District, Guangzhou, Guangdong, 510080, China.
  • Ximeng W; Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Zhong Shan Er Road No. 106, Yue Xiu District, Guangzhou, Guangdong, 510080, China.
  • Caojin Z; Global Health Research Center, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China.
BMC Cardiovasc Disord ; 24(1): 198, 2024 Apr 05.
Article en En | MEDLINE | ID: mdl-38580946
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).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Foramen Oval Permeable / Trastornos Migrañosos Límite: Humans Idioma: En Revista: BMC Cardiovasc Disord Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Foramen Oval Permeable / Trastornos Migrañosos Límite: Humans Idioma: En Revista: BMC Cardiovasc Disord Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido