Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

NCT ID: NCT05775354

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Atrial Fibrillation Heart Failure Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Early diagnosis strategy

RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography

Group Type EXPERIMENTAL

Early diagnosis strategy

Intervention Type DIAGNOSTIC_TEST

RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography

Usual primary care

No measurements

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early diagnosis strategy

RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Monika Hollander, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Hollander, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL82944.041.23

Identifier Type: -

Identifier Source: org_study_id

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