Study of Myasthenic Crisis in China (NCT04837625) | Clinical Trial Compass
RecruitingNot Applicable
Study of Myasthenic Crisis in China
China300 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MG-ADL of 3 years after off-mechanical ventilation