Myasthaenia GravisNCT06707727
Characteristics and Prognostic Outcomes of Diaphragmatic Ultrasound in Myasthenia Gravis
An observational study of Myasthaenia Gravis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. The main question it aims to answer is: Does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? Participants diagnosed as myasthenia gravis… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myasthaenia Gravis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors; Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins; Repeated electrical stimulation examination showed a decrease in wave amplitude.
Who may be able to join
- 1: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors
- 2: Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins
- 3: Repeated electrical stimulation examination showed a decrease in wave amplitude.
Who cannot join
- 1: Patients with lung disease or heart failure, or a history of non-invasive ventilator or tracheotomy
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
The goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. The main question it aims to answer is:
Does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? Participants diagnosed as myasthenia gravis will take the diaphragm ultrasound examinations.
- Conditions
- Myasthaenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| myasthenia gravis | Not described | |
| controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
QMG changes
Measured: 6 months
Secondary outcomes (2)
Changes in medication type or dose
acetylcholinesterase inhibitors, glucocorticoid, immunosuppressant
Measured: 6 months
respiratory infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthaenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Xiao, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707727
- Sponsor's protocol ID
- 2024-050-01
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes