Coronary Artery Disease Clinical Trial
— RED-LRGPOfficial title:
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
Verified date | February 2024 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
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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