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NCT05775354 Clinical Trial

Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Coronary Artery Disease Clinical Trial

— RED-LRGP  

Official title:
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05775354
Other study ID # NL82944.041.23
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date October 2026

Study information
Verified date February 2024
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1476
Est. completion date October 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coronary artery disease 1 year
Primary Atrial fibrillation 1 year
Primary Heart failure 1 year
Primary Valvular heart disease 1 year
Secondary Echocardiographic abnormalities 1 year
Secondary Health-related quality of life 1 year
Secondary CVD family history and women's reproductive history 1 year
Secondary Cardiovascular risk profile 1 year
Secondary Costs 1 year
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