Study of Myasthenic Crisis in China

NCT04837625 | Recruiting

• 1 other identifier: MC2020883
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Obtain epidemiological data of MC in China;
2. 2.Establish a standardized registration system for MC patients in China;
3. 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.

Conditions

Myasthenia Gravis; Myasthenic Crisis

Outcome Measures

Primary Outcomes (1)

• MG-ADL of 3 years after off-mechanical ventilation

  Sep,2026

Study Arms (1)

Myasthenic Crisis Cohort

Other: no interventions

Interventions

no interventions OTHER

no interventions

Myasthenic Crisis Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from multiple centers across China.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Xiao Huan, MD

CONTACT

+8618351973910; hx941223@163.com

Susan Luo, MD;PHD

CONTACT

SusanRo_36@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: October 1, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)