Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

NCT05775354 | Enrolling By Invitation

• 1 other identifier: NL82944.041.23
• Study Type: interventional
• Target: 1,476
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atrial Fibrillation; Heart Failure; Valvular Heart Disease

Keywords

early diagnosis; cardiovascular diseases; cohort study; primary health care

Outcome Measures

Primary Outcomes (4)

• Coronary artery disease

  1 year

• Atrial fibrillation

  1 year

• Heart failure

  1 year

• Valvular heart disease

  1 year

Secondary Outcomes (5)

• Echocardiographic abnormalities

  1 year

• Health-related quality of life

  1 year

• CVD family history and women's reproductive history

  1 year

• Cardiovascular risk profile

  1 year

• Costs

  1 year

Study Arms (2)

Early diagnosis strategy

EXPERIMENTAL

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

Diagnostic Test: Early diagnosis strategy

Usual primary care

NO INTERVENTION

No measurements

Interventions

Early diagnosis strategy DIAGNOSTIC_TEST

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

Early diagnosis strategy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-80 years
• Being a participant of LRGP
• Having indicated in the LRGP informed consent to be interested in participating in further research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Heart Failure; Heart Valve Diseases; Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Hollander, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)