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A Multicenter Prospective Registration Study of Myasthenic Crisis in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837625
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Chongbo Zhao, Huashan Hospital

Study Description
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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
Myasthenia Gravis Myasthenic Crisis Other: no interventions

Study Design
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Study Type : Observational
Estimated 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 : October 1, 2020
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Myasthenic Crisis Cohort Other: no interventions
no interventions


Outcome Measures
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Primary Outcome Measures :
  1. MG-ADL of 3 years after off-mechanical ventilation [ Time Frame: Sep,2026 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be recruited from multiple centers across China.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837625


Contacts
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Contact: Xiao Huan, MD +8618351973910 hx941223@163.com
Contact: Susan Luo, MD;PHD SusanRo_36@hotmail.com

Locations
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China, Shanghai
Huashan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xiao Huan, MD       hx941223@163.com   
Contact: Susan Luo, MD；PHD       SusanRo_36@hotmail.com   
Sponsors and Collaborators
Huashan Hospital
More Information
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Responsible Party: Chongbo Zhao, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04837625    
Other Study ID Numbers: MC2020883
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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