SchizophreniaSCHIZO-CVNCT05174533
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia
An observational study of Schizophrenia, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial summary
Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Data collection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 12 Jul 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged of 40 and more with schizophrenia
Who may be able to join
- male or female
- aged of 40 and more
- with schizophrenia
- agreeing to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Epsmd de l'Aisne
Prémontré, Grand Est, 02320
About this study
Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.
Read the detailed description
The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Data collection
- Keywords
- schizophrenia, cardiovascular disorders, prevalence
- Medical subject headings
- Schizophrenia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| with schizophrenia | "with schizophrenia" group : patients aged 40 and more with schizophrenia Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS morphology
variation of QRS waves according a standard 12-lead ECG
Measured: Day 0
Secondary outcomes (1)
cardiac rhythm
cardiac rhythm disorder according a standard 12-lead ECG
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start12 Jan 2022
- Primary completion12 May 2022 (estimated)
- Study completion12 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174533
- Sponsor's protocol ID
- 2021-011-SCHIZO-CV
- Acronym
- SCHIZO-CV
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia
- ClinicalTrials.gov ID
- NCT05174533
- Acronym / sponsor ID
- SCHIZO-CV / 2021-011-SCHIZO-CV
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, cardiovascular disorders, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 12 May 2022 (estimated)
- Study completion
- 12 Jul 2022 (estimated)
- First posted
- 30 Dec 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.
Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.
Detailed description
The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with schizophrenia | – | Other: Data collection"with schizophrenia" group : patients aged 40 and more with schizophrenia |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged of 40 and more with schizophrenia
Key inclusion criteria (4 listed)
- male or female
- aged of 40 and more
- with schizophrenia
- agreeing to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Data collectionelectrocardiogram | Other | with schizophrenia |
Primary outcome
QRS morphology
Time frame: Day 0
variation of QRS waves according a standard 12-lead ECG
1 secondary outcome
cardiac rhythm
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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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.
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 Schizophrenia, run by Université de Reims Champagne-Ardenne 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CURRS Université de Reims Champagne-Ardenne (0326918822 ext. +33, currs@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QRS morphology (time frame: Day 0). 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 1 Feb 2022.