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Clinical Trials/NCT05775354
NCT05775354
Enrolling By Invitation
Not Applicable

Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

UMC Utrecht1 site in 1 country1,476 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
UMC Utrecht
Enrollment
1476
Locations
1
Primary Endpoint
Coronary artery disease
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
October 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monika Hollander, MD, PhD

MD, PhD

UMC Utrecht

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.

Outcomes

Primary Outcomes

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 Outcomes

  • CVD family history and women's reproductive history(1 year)
  • Echocardiographic abnormalities(1 year)
  • Health-related quality of life(1 year)
  • Cardiovascular risk profile(1 year)
  • Costs(1 year)

Study Sites (1)

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