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OpenTrials
Completed

NCT Number: NCT04838509

Diagnoses Associated With Persistent Elevation of Creatine Kinase

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.

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Key information

Conditions

Creatine Kinase Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

retrospective descriptive without intervention

Primary outcomes

  1. Diagnosis

    Time frame: 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 outcomes

  1. Muscle biopsy

    Time frame: 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

  2. Clinical presentation

    Time frame: at the end of all investigations, an average of 12 months

    association between the initial clinical presentation and the final diagnosis

  3. Paraclinical presentation

    Time frame: at the end of all investigations, an average of 12 months

    association between the initial paraclinical presentation and the final diagnosis

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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