Coronary Artery DiseaseRED-LRGPNCT05775354
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
A study testing Early diagnosis strategy in people with Coronary Artery Disease and Atrial Fibrillation, run by UMC Utrecht at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation, Heart Failure
- What is being tested?
- Early diagnosis strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,476 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50-80 years
- Being a participant of LRGP
- Having indicated in the LRGP informed consent to be interested in participating in further research.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Early diagnosis strategy
- Keywords
- early diagnosis, cardiovascular diseases, cohort study, primary health care
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Heart Failure, Heart Valve Diseases, Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early diagnosis strategyDiagnostic test
RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Early diagnosis strategy | Experimental | RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography Receives: Diagnostic Test: Early diagnosis strategy |
| Usual primary care | No intervention | No measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease
Measured: 1 year
Atrial fibrillation
Measured: 1 year
Heart failure
Measured: 1 year
Valvular heart disease
Measured: 1 year
Secondary outcomes (5)
Echocardiographic abnormalities
Measured: 1 year
Health-related quality of life
Measured: 1 year
CVD family history and women's reproductive history
Measured: 1 year
Cardiovascular risk profile
Measured: 1 year
Costs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Nov 2023
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Hollander, MD, PhD, UMC Utrecht
- Investigators
- Monika Hollander, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775354
- Sponsor's protocol ID
- NL82944.041.23
- Acronym
- RED-LRGP
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
- ClinicalTrials.gov ID
- NCT05775354
- Acronym / sponsor ID
- RED-LRGP / NL82944.041.23
- Keywords
- early diagnosis, cardiovascular diseases, cohort study, primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,476 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early diagnosis strategy | Experimental | Diagnostic Test: Early diagnosis strategyRED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography |
| Usual primary care | No intervention | –No measurements |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50-80 years
- Being a participant of LRGP
- Having indicated in the LRGP informed consent to be interested in participating in further research.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early diagnosis strategyRED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography | Diagnostic test | Early diagnosis strategy |
Primary outcome
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
5 secondary outcomes
Echocardiographic abnormalities
Time frame: 1 year
Health-related quality of life
Time frame: 1 year
CVD family history and women's reproductive history
Time frame: 1 year
Cardiovascular risk profile
Time frame: 1 year
Costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Hollander, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early diagnosis strategy in people with Coronary Artery Disease and Atrial Fibrillation, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery disease (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.