Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project (RED-LRGP)

February 21, 2024 updated by: Monika Hollander, MD, PhD, UMC Utrecht

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary artery disease
Time Frame: 1 year
1 year
Atrial fibrillation
Time Frame: 1 year
1 year
Heart failure
Time Frame: 1 year
1 year
Valvular heart disease
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Echocardiographic abnormalities
Time Frame: 1 year
1 year
Health-related quality of life
Time Frame: 1 year
1 year
CVD family history and women's reproductive history
Time Frame: 1 year
1 year
Cardiovascular risk profile
Time Frame: 1 year
1 year
Costs
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Monika Hollander, MD PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82944.041.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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