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NCT Number: NCT04837625

Study of Myasthenic Crisis in China

This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including:

1. Obtain epidemiological data of MC in China; 2. Establish a standardized registration system for MC patients in China; 3. Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenic Crisis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Susan Luo, MD；PHD

CONTACT

[email protected]

Xiao Huan, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical history and signs of fluctuating weakness and fatigability;
  • seropositivity forAChR/MuSKantibodies;
  • If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required;
  • Crisis: a serious, life-threatening, rapid worsening of MG requiring intubation or noninvasive ventilation to avoid intubation.
  • Impending crisis: rapid clinical worsening of MG that, in the opinion of the treating physician, could lead to crisis in the short term (days to weeks) with blood gases suggest hypoxia (oxygen saturation <95%) or elevated carbon dioxide (paco2>50mmHg).

Exclusion criteria

  • the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG.
  • except when intubation or noninvasive ventilation are employed during routine postoperative management.

Treatment and study plan

No interventions

Other

no interventions

Primary outcomes

  1. MG-ADL of 3 years after off-mechanical ventilation

    Time frame: Sep,2026

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Luo, MD;PHD

CONTACT

[email protected]

Xiao Huan, MD

CONTACT

[email protected]

+8618351973910

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

A Multicenter Prospective Registration Study of Myasthenic Crisis in China

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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