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Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project (RED-LRGP)

U

UMC Utrecht

Status

Invitation-only

Conditions

Coronary Artery Disease
Atrial Fibrillation
Valvular Heart Disease
Heart Failure

Treatments

Diagnostic Test: Early diagnosis strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT05775354
NL82944.041.23

Details and patient eligibility

About

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.

Enrollment

1,476 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,476 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Carlijn Vermeer, Msc; Monika Hollander, MD PhD

Data sourced from clinicaltrials.gov

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