Screening of Malignant Hyperthermia Susceptible Individuals

Malignant Hyperthermia Clinical Trial

Official title:

Molecular Genetics Study on Screening of Malignant Hyperthermia Susceptible Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402839
• Other study ID #: MR-11-22-002000
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: February 2041

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: Yinyin Qu, M.D.
• Phone: +8613466759889
• Email: quyinyin[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study intends to target patients who underwent surgery under general anesthesia during the study period and developed malignant hyperthermia during or after surgery. Therefore, the total sample size was estimated to be about 50 people based on the past incidence of this rare disease. Every year, about 20 patients and their families who developed malignant hyperthermia during or after surgery will participate in this nationwide study (estimated by the current incidence of malignant hyperthermia), and about 1-5 patients will be admitted to Peking University Third Hospital participate in this research. Relevant specimens were collected from malignant hyperthermia (MH) patients and their family members for genetic analysis to determine the mutation of MH-related pathogenic gene loci.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2041
• Est. primary completion date: February 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing surgery under general anesthesia during the study period developed malignant hyperthermia during or after surgery.

Exclusion Criteria:

• Malignant hyperthermia was ruled out by later treatment and diagnosis;
• The patient or family member refuses to be recruited.

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Malignant Hyperthermia

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole exome sequencing		immediately after MH was diagnosed