Creatine KinaseNCT04838509
Diagnoses Associated With Persistent Elevation of Creatine Kinase
An observational study of Creatine Kinase and Muscular Diseases, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Creatine Kinase, Muscular Diseases
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 24 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in the ward of internal medicin of Nancy University Hospital or UNEOS General Hospital of Metz between 2009 and 2018.
Who may be able to join
- 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
Who cannot join
- known neuro-muscular disease causing elevation of creatine kinase
- evident post-traumatic cause responsible for the elevation of creatine kinase
- incomplete medical records
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- no intervention
- Keywords
- Creatine Kinase
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
retrospective descriptive without intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with elevated creatine kinase | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of all investigations, an average of 12 months
Secondary outcomes (3)
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
Measured: at the end of all investigations, an average of 12 months
Clinical presentation
association between the initial clinical presentation and the final diagnosis
Measured: at the end of all investigations, an average of 12 months
Paraclinical presentation
association between the initial paraclinical presentation and the final diagnosis
Measured: at the end of all investigations, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 May 2021
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Creatine KinaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lev VOLKOV, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838509
- Sponsor's protocol ID
- 2021PI034
- Status last verified
- Jun 2021
- First submitted
- 4 Apr 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnoses Associated With Persistent Elevation of Creatine Kinase
- ClinicalTrials.gov ID
- NCT04838509
- Acronym / sponsor ID
- 2021PI034
- Conditions
- Creatine Kinase, Muscular Diseases
- Keywords
- Creatine Kinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with elevated creatine kinase | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in the ward of internal medicin of Nancy University Hospital or UNEOS General Hospital of Metz between 2009 and 2018.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- known neuro-muscular disease causing elevation of creatine kinase
- evident post-traumatic cause responsible for the elevation of creatine kinase
- incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionretrospective descriptive without intervention | Other | Patients with elevated creatine kinase |
Primary outcome
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
3 secondary outcomes
Muscle biopsy
Time frame: 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
Paraclinical presentation
Time frame: at the end of all investigations, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Creatine Kinase and Muscular Diseases, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: at the end of all investigations, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.