NCT05174533

Brief 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. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 13, 2021

Last Update Submit

January 17, 2022

Conditions

Schizophrenia

Keywords

schizophreniacardiovascular disordersprevalence

Outcome Measures

Primary Outcomes (1)

  • QRS morphology

    variation of QRS waves according a standard 12-lead ECG

    Day 0

Secondary Outcomes (1)

  • cardiac rhythm

    Day 0

Study Arms (1)

with schizophrenia

"with schizophrenia" group : patients aged 40 and more with schizophrenia

Other: Data collection

Interventions

Data collectionOTHER

electrocardiogram

with schizophrenia

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged of 40 and more with schizophrenia

You may qualify if:

  • male or female
  • aged of 40 and more
  • with schizophrenia
  • agreeing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epsmd de l'Aisne

Prémontré, Grand Est, 02320, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaCardiovascular Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

CURRS Université de Reims Champagne-Ardenne

CONTACT

0326918822currs@univ-reims.fr

Coralie BARBE, MD

CONTACT

0326918822currs@univ-reims.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 30, 2021

Study Start

January 12, 2022

Primary Completion

May 12, 2022

Study Completion

July 12, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)