RED-LRGP: Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Sponsor

UMC Utrecht (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05775354

Collaborator

(none)

1,500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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) and heart failure (HF) 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Atrial Fibrillation Heart Failure	Diagnostic Test: Early diagnosis strategy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Early diagnosis strategy

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

Diagnostic Test: Early diagnosis strategy

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

No Intervention: Usual primary care

No measurements

Outcome Measures

Primary Outcome Measures

Coronary artery disease [1 year]
Expert panel diagnosis by evaluation of all available diagnostic information
Atrial fibrillation [1 year]
Expert panel diagnosis by evaluation of all available diagnostic information
Heart failure [1 year]
Expert panel diagnosis by evaluation of all available diagnostic information

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Being a participant of LRGP
Aged 50-80 years
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.