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Enrolling by invitation NCT05775354

Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

No phase Interventional Coronary Artery Disease Atrial Fibrillation Heart Failure Valvular Heart Disease

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early diagnosis strategy.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Atrial Fibrillation, Heart Failure, Valvular Heart Disease. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Early diagnosis strategy
    RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography

Primary outcome measures

  • Coronary artery disease [Time frame: 1 year]
  • Atrial fibrillation [Time frame: 1 year]
  • Heart failure [Time frame: 1 year]
  • Valvular heart disease [Time frame: 1 year]
Secondary outcome measures (5)
  • Echocardiographic abnormalities [Time frame: 1 year]
  • Health-related quality of life [Time frame: 1 year]
  • CVD family history and women's reproductive history [Time frame: 1 year]
  • Cardiovascular risk profile [Time frame: 1 year]
  • Costs [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • UMC Utrecht — Utrecht

Identifiers

NCT: NCT05775354 · NL82944.041.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗