| NCT ID | NCT04837625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04837625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04837625 currently recruiting?
Yes, NCT04837625 is actively recruiting participants. Contact the research team at hx941223@163.com for enrollment information.
Where is the NCT04837625 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04837625 clinical trial?
NCT04837625 is sponsored by Huashan Hospital. The trial plans to enroll 300 participants.