Diagnoses Associated With Persistent Elevation of Creatine Kinase

Completed

• Conditions: Muscular Diseases; Creatine Kinase
• Interventions: Other: no intervention

• Registration Number: NCT04838509
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Study Start: 2021-05-01
• Status Verified: 2021-06
• Primary Completion: 2021-06-24
• Study Completion: 2021-06-24
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with elevated creatine kinase	no intervention	-

Primary Outcome Measures

Name	Time	Method
Diagnosis	at the end of all investigations, an average of 12 months	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

Secondary Outcome Measures

Name	Time	Method
Muscle biopsy	at the end of all investigations, an average of 12 months	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
Clinical presentation	at the end of all investigations, an average of 12 months	association between the initial clinical presentation and the final diagnosis
Paraclinical presentation	at the end of all investigations, an average of 12 months	association between the initial paraclinical presentation and the final diagnosis

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France