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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04838509
Other study ID # 2021PI034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date June 24, 2021

Study information

Verified date June 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date June 24, 2021
Est. primary completion date June 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients hospitalised in a ward of internal medicin - having a persistent elevation of serum creatine kinase >3 times the upper normal laboratory value, repeated for 2 times Exclusion Criteria: - known neuro-muscular disease causing elevation of creatine kinase - evident post-traumatic cause responsible for the elevation of creatine kinase - incomplete medical records

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
retrospective descriptive without intervention

Locations

Country Name City State
France CHRU Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis The final diagnosis, as written in the medical record at the end of the investigations in the ward of internal medicin, responsible for the elevation of creatine kinase between: inflammatory myositis, mitochondrial myopathy, muscular dystrophy, non neuromuscular pathology at the end of all investigations, an average of 12 months
Secondary Muscle biopsy Among the patients who underwent a muscle biopsy, number of anormal biopsies that contributed to make the final diagnosis responsible of the elevation of creatine kinase at the end of all investigations, an average of 12 months
Secondary Clinical presentation association between the initial clinical presentation and the final diagnosis at the end of all investigations, an average of 12 months
Secondary Paraclinical presentation association between the initial paraclinical presentation and the final diagnosis at the end of all investigations, an average of 12 months
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