Back to resultsReving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project (RED-LRGP)
Primary Purpose
Coronary Artery Disease, Atrial Fibrillation, Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early diagnosis strategy
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring early diagnosis, cardiovascular diseases, cohort study, primary health care
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early diagnosis strategy
Usual primary care
Arm Description
RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography
No measurements
Outcomes
Primary Outcome Measures
Coronary artery disease
Expert panel diagnosis by evaluation of all available diagnostic information
Atrial fibrillation
Expert panel diagnosis by evaluation of all available diagnostic information
Heart failure
Expert panel diagnosis by evaluation of all available diagnostic information
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05775354
Brief Title
Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
Acronym
RED-LRGP
Official Title
Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atrial Fibrillation, Heart Failure
Keywords
early diagnosis, cardiovascular diseases, cohort study, primary health care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early diagnosis strategy
Arm Type
Experimental
Arm Description
RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography
Arm Title
Usual primary care
Arm Type
No Intervention
Arm Description
No measurements
Intervention Type
Diagnostic Test
Intervention Name(s)
Early diagnosis strategy
Intervention Description
RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography
Primary Outcome Measure Information:
Title
Coronary artery disease
Description
Expert panel diagnosis by evaluation of all available diagnostic information
Time Frame
1 year
Title
Atrial fibrillation
Description
Expert panel diagnosis by evaluation of all available diagnostic information
Time Frame
1 year
Title
Heart failure
Description
Expert panel diagnosis by evaluation of all available diagnostic information
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlijn Vermeer, Msc
Phone
+31627744390
Email
c.j.c.vermeer-3@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Hollander, MD PhD
Phone
+31628038693
Email
m.hollander-2@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Hollander, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
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