Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and pregnancy morbidity in patients with persistently positive antiphospholipid antibodies (aPLs). However, large-scale research on general population with persistent aPLs has been lacking. This project proposes to establish the first multicenter cohort of patients with persistently positive aPLs in China and conduct a comprehensive clinical phenotyping study. Based on traditional phenotypes of thrombotic and pregnancy events, the focus will be on extra-standard clinical phenotypes and prospective assessment of event risk and prognosis in aPL-positive population. A prospective analysis of extra-standard antibodies will also be conducted to recommend detection criteria for extra-standard antibody application in China and to assess their clinical significance.
Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks (CAPSTONE) is a national research network created to register patients with persistent aPLs. We aim at enrolling 2000 patients from a total of six centers, lead by the Peking Union Medical College Hospital (PUMCH). The aPLs assay will be validated in the central lab in PUMCH. All patients will be followed every six months, and up to three years. Thrombotic and pregnancy events related to aPLs will be recorded, as well as extra-criteria clinical phenotypes.
Study Type
OBSERVATIONAL
Enrollment
2,000
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Shunyi Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGThe Affilicated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Second Affiliated Hospical of Nanchang University
Nanchang, Jiangxi, China
RECRUITING...and 8 more locations
Vascular thrombosis related to aPLs
Venous thrombosis, arterial thrombosis, microscopic thrombosis
Time frame: 36 months
Pregnancy morbidity related to aPLs
One or more unexplained deaths of a morphologically normal fetus at ≥10 weeks gestation, or one or more premature births of a morphologically normal neonate before 34 weeks gestation because of eclampsia, preeclampsia, or placental insufficiency, or three or more consecutive spontaneous pregnancy losses at \<10 weeks gestation, unexplained by chromosomal abnormalities or by maternal anatomic or hormonal causes.
Time frame: 36 months
antiphospholipid antibody profile
IgG and/or IgM anticardiolipin (ACL) antibodies, IgG and/or IgM anti-beta2-glycoprotein (GP), Lupus anticoagulant (LA) activity, IgA ACL/anti-β2-GP I,anti-annexin 5 antibody, anti-protein C, anti-protein S, anti-vimentin/cardiolipin complex, and anti-lysobisphosphatidic acid (LBPA) et al.
Time frame: 36 months
Extra-criteria manifestations
Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.