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Natural history, clinical outcomes and predictors of disease course in paediatric IgA vasculitis: protocol for a multicentre prospective cohort study in Guangxi Zhuang Autonomous Region, China

Por: Jiang · H.-H. · Meng · X.-Y. · Liang · Q. · Li · R.-J. · Tang · Q. · Huang · L. · Yun · X. · Shan · Q.-W. · Chen · X.-Q.
Introduction IgA vasculitis (IgAV, formerly Henoch-Schönlein purpura) is a systemic small-vessel vasculitis. The aetiology of IgAV is multifactorial, involving environmental triggers in genetically susceptible individuals. Evolving socioeconomic and environmental factors may be altering the contemporary aetiological and precipitant spectrum of IgAV. Prospective observational studies are therefore crucial for elucidating disease management, prognostic factors and long-term outcomes. Although numerous studies exist on paediatric IgAV, prospective cohort data remain limited. This multicentre prospective observational study aims to characterise the natural history, aetiological/precipitant spectrum, incidence and outcomes of gastrointestinal and renal involvement, factors influencing therapeutic efficacy and the predictive value of biomarkers for disease activity.

Methods and analysis

We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.

Trial registration number

ChiCTR2500099716.

PlacEntal Acute atherosis RefLecting Subclinical systemic atherosclerosis in women up to 20 years after pre-eclampsia (PEARLS): research protocol for a cohort study

Por: Jansen · G. · Alers · R.-J. · Janssen · E. B. · Jorissen · L. M. · Morina - Shijaku · E. · Severens-Rijvers · C. · van t Hof · A. · van Drongelen · J. · Scholten · R. R. · Al-Nasiry · S. · Stevens · D. · Ganzevoort · W. · Gordijn · S. · Cornette · J. · Mihl · C. · Kietelaer · B. · Ghos
Introduction

Despite being a leading cause of female morbidity and mortality, female-specific cardiovascular disease (CVD) is understudied, underdiagnosed and undertreated. Pregnancy complications involving the placenta, including pre-eclampsia, pregnancy-induced hypertension and foetal growth restriction, are thought to reflect global maternal vascular derangements that indicate a twofold to eightfold increased risk of future CVD. This calls for a better understanding of female cardiovascular pathophysiology to allow development of targeted screening and prevention strategies.

Acute atherosis is a placental vascular lesion, which histologically resembles systemic atherosclerosis. The PlacEntal Acute atherosis RefLecting Subclinical atherosclerosis study investigates the association between placental acute atherosis lesions and subclinical systemic atherosclerosis up to 20 years postpartum.

This study will improve our understanding of the relationship between pregnancy complications and CVD to identify potential prevention targets and treatments. In addition, it could determine whether the placenta can improve identification of young women at high risk of CVD. These women could benefit from risk-reducing interventions.

Methods and analysis

This longitudinal prospective cohort study will include women who are either currently pregnant or from a historical cohort. Both groups will have placental histopathology and a single postpartum CVD assessment. The CVD assessment will include medical history taking, blood tests, electrocardiography and echocardiography. Additionally, coronary CT angiography focusing on the presence of atherosclerotic plaques and calcium score will be carried out.

The currently pregnant women will either have a pre-eclamptic pregnancy (pre-eclamptic group) or an uncomplicated normotensive pregnancy (uncomplicated group), and their placenta will be collected prospectively. The single CVD assessment will be carried out 6–36 months postpartum.

Women from the historical cohort had a pre-eclamptic pregnancy 10–20 years ago. Placental tissue is available for reanalysis. The single CVD assessment will take place immediately and corresponds with 10–20 years postpartum.

Exclusion criteria are contraindications to diagnostic assessment necessities: iodinated contrast, beta-blockers or glyceryl trinitrate. Women with uncomplicated pregnancies will be excluded if they have a pre-existing auto-immune condition, chronic hypertension or diabetes mellitus. In the pre-eclamptic group, there are no additional exclusion criteria.

Ethics and dissemination

Ethical approval was granted by the Medical Ethics Committee in Maastricht University Medical Centre+ (NL52556.068.15/METC152019). Participants will give written informed consent. Results will be shared in peer-reviewed journals and conference presentations.

Trial registration number

NCT05500989; ClinicalTrials.gov Identifier.

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