Prevalence of Cardiovascular Disorders in Patients Aged 4... | NCT05174533

Studies
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia

NCT05174533

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Feb 1, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Schizophrenia

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2022Actual

Primary Completion Date

May 12, 2022Estimated

Completion Date

Jul 12, 2022Estimated

First Submitted Date

Dec 13, 2021

First Submission Date that Met QC Criteria

Dec 13, 2021

First Posted Date

Dec 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2022

Last Update Posted Date

Feb 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with schizophrenia		"with schizophrenia" group : patients aged 40 and more with schizophrenia	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	electrocardiogram	with schizophrenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QRS morphology	variation of QRS waves according a standard 12-lead ECG	Day 0

Secondary Outcomes

Measure	Description	Time Frame
cardiac rhythm	cardiac rhythm disorder according a standard 12-lead ECG	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients aged of 40 and more with schizophrenia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CURRS Université de Reims Champagne-Ardenne	Contact	0326918822	+33	currs@univ-reims.fr
Coralie BARBE, MD	Contact	0326918822	+33	currs@univ-reims.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Epsmd de l'Aisne	Recruiting	Prémontré	Grand Est	02320	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided