A Multicenter Phenotype-Genotype Analysis of DM1 Patients in China
NCT ID: NCT06101940
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2021-08-01
2032-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DM1 patients
Patient cohort
MRI scan
Brain MRI scan to evaluate the integrity of the nervous system; lower limb muscle MRI scan to evaluate fat infiltration in skeletal muscles of the lower limb
Electrocardiography
Standard 12-lead electrocardiography or Holter monitoring performed to assess cardiac conduction abnormalities and arrhythmias in patients with DM1.
Pulmonary function test
Comprehensive pulmonary function testing including spirometry to assess respiratory muscle weakness and restrictive lung disease in DM1 patients.
Interventions
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MRI scan
Brain MRI scan to evaluate the integrity of the nervous system; lower limb muscle MRI scan to evaluate fat infiltration in skeletal muscles of the lower limb
Electrocardiography
Standard 12-lead electrocardiography or Holter monitoring performed to assess cardiac conduction abnormalities and arrhythmias in patients with DM1.
Pulmonary function test
Comprehensive pulmonary function testing including spirometry to assess respiratory muscle weakness and restrictive lung disease in DM1 patients.
Eligibility Criteria
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Inclusion Criteria
* With enough cognitivie ability to understand the content and sign the informed consent form
* With CTG repeats \>50 in DMPK gene, revealed by PCR test
Exclusion Criteria
* With comorbidities such as traumatic brain injury and cranial tumors
* A history of alcoholism, psychotropic substance abuse, etc.
* Patients with severe medical conditions and unstable vital signs that cannot tolerate the tests.
* Female in pregnancy
18 Years
80 Years
ALL
Yes
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Chongbo Zhao
Professor
Principal Investigators
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Chongbo Zhao, PhD
Role: STUDY_DIRECTOR
Huashan Hospital
Locations
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Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Wuhan University People's Hospital
Wuhan, Hubei, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First People's Hospital of Yancheng
Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University）
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Gaoxin Hospital
Xi’an, Shanxi, China
Xi'an People's Hospital
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Yunnan Provincial People's Hospital
Kunming, Yunnan, China
Huashan Hospital
Shanghai, , China
Countries
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Other Identifiers
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KY2020-008
Identifier Type: -
Identifier Source: org_study_id
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