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OpenTrials
Enrolling by Invitation

NCT Number: NCT05775354

Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Cardiovascular Diseases Coronary Disease Disease Heart Diseases Heart Failure Heart Valve Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Valvular Heart Disease Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early diagnosis strategy

Diagnostic Test

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

Primary outcomes

  1. Coronary artery disease

    Time frame: 1 year

  2. Atrial fibrillation

    Time frame: 1 year

  3. Heart failure

    Time frame: 1 year

  4. Valvular heart disease

    Time frame: 1 year

Secondary outcomes

  1. Echocardiographic abnormalities

    Time frame: 1 year

  2. Health-related quality of life

    Time frame: 1 year

  3. CVD family history and women's reproductive history

    Time frame: 1 year

  4. Cardiovascular risk profile

    Time frame: 1 year

  5. Costs

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: RED-LRGP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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