Diagnoses Associated With Persistent Elevation of Creatine Kinase

NCT04838509 | Completed DMC

• 1 other identifier: 2021PI034
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Creatine Kinase; Muscular Diseases

Keywords

Creatine Kinase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Muscle biopsy

  at the end of all investigations, an average of 12 months

• Clinical presentation

  at the end of all investigations, an average of 12 months

• Paraclinical presentation

  at the end of all investigations, an average of 12 months

Study Arms (1)

Patients with elevated creatine kinase

Other: no intervention

Interventions

no intervention OTHER

retrospective descriptive without intervention

Patients with elevated creatine kinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalised in the ward of internal medicin of Nancy University Hospital or UNEOS General Hospital of Metz between 2009 and 2018.

You may qualify if:

• 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

You may not qualify if:

• known neuro-muscular disease causing elevation of creatine kinase
• evident post-traumatic cause responsible for the elevation of creatine kinase
• incomplete medical records

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 9, 2021
• Study Start: May 1, 2021
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

FR (1)