Reviving Early Diagnosis of Cardiovascular Disease in the... | NCT05775354

Studies
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

NCT05775354

Sponsor

UMC Utrecht

Status

Enrolling by invitation

Last Update Posted

Feb 23, 2024Actual

Enrollment

1,476Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease
Atrial Fibrillation
Heart Failure
Valvular Heart Disease

Interventions

Early diagnosis strategy

Countries

Netherlands

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

May 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 20, 2023Actual

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

Feb 21, 2024

Last Update Posted Date

Feb 23, 2024Actual

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

The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project.

The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,476Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early diagnosis strategy	Experimental	RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography	Diagnostic Test: Early diagnosis strategy
Usual primary care	No Intervention	No measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early diagnosis strategy	Diagnostic Test	RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography	Early diagnosis strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary artery disease		1 year
Atrial fibrillation		1 year
Heart failure		1 year
Valvular heart disease		1 year

Secondary Outcomes

Measure	Description	Time Frame
Echocardiographic abnormalities		1 year
Health-related quality of life		1 year
CVD family history and women's reproductive history

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 50-80 years
Being a participant of LRGP
Having indicated in the LRGP informed consent to be interested in participating in further research.

Exclusion Criteria:

Diagnosed with coronary artery disease and atrial fibrillation and heart failure.
Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment.
Not willing to give written informed consent for RED-LRGP.
Not allowing incidental findings to be reported to him/herself or their own GP.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Monika Hollander, MD PhD	UMC Utrecht	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC Utrecht		Utrecht		3584CX	Netherlands

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
D003324	Coronary Artery Disease
D001281	Atrial Fibrillation
D006333	Heart Failure
D006349	Heart Valve Diseases
D004194	Disease
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided