Diagnoses Associated With Persistent Elevation of Creatine Kinase

June 24, 2021 updated by: Lev VOLKOV, Central Hospital, Nancy, France
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Chru Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with elevated creatine kinase
Other: no intervention
retrospective descriptive without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of all investigations, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of all investigations, an average of 12 months
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
at the end of all investigations, an average of 12 months
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
at the end of all investigations, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

June 24, 2021

Study Completion (Actual)

June 24, 2021

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI034

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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