A Multicenter Prospective Registration Study of Myasthenic Crisis in China

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04837625
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis; Myasthenic Crisis	Other: no interventions

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter Prospective Registration Study of Myasthenic Crisis in China
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2026
• Anticipated Study Completion Date: Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Myasthenic Crisis Cohort	Other: no interventions; no interventions

Outcome Measures

Primary Outcome Measures

1. MG-ADL of 3 years after off-mechanical ventilation [Sep,2026]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• (1)clinical history and signs of fluctuating weakness and fatigability; (2)seropositivityforAChR/MuSKantibodies; (3)If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required; (4)A serious, life-threatening, rapid worsening of MG and potential airway compromise from ventilatory or bulbar dysfunction.

Exclusion Criteria:

• the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chongbo Zhao, Professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT04837625
• Other Study ID Numbers: MC2020883
• First Posted: Apr 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myasthenia Gravis

Study Results

No Results Posted as of Apr 8, 2021