Diagnoses Associated With Persistent Elevation of Creatine Kinase

Muscular Diseases Clinical Trial

Official title:

Diagnoses Associated With Persistent Elevation of Creatine Kinase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838509
• Other study ID #: 2021PI034
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Creatine Kinase
• Muscular Diseases

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