Coronary calcium scoring as first-line test to detect and exclude coronary artery disease in GP patients with stable chest pain

Coronary calcium scoring as first-line test to detect and exclude coronary artery disease in GP patients with stable chest pain - CONCRETE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55495

Enrollment

1600

Registered

2018-11-12

Start date

2018-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease coronary heart disease

Interventions

Implementation of direct access to CT calcium scoring for patients with chest discomfort in GP setting. Patients in both clusters will be asked for consent to fill in questionnaires regarding compla

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cluster: GPs willing to be included in the trial in the collaborating GP organizations. Individuals: Patients with non-acute chest discomfort, either atypical AP or aspecific chest pain, with indication for further evaluation to diagnose or exclude CAD as determined by the GP

Exclusion criteria

Exclusion criteria: Individuals: Men under 40 years, women under 45 years Unwilling to provide written informed consent for the individual level outcomes (secondary outcomes) Pregnancy Prior CAD (PCI/ CABG/ infarct/ stable CAD)

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints (cluster based): To determine the increase in detection / treatment rate of CAD in GP offices with the calcium score-based strategy, compared to GP offices with the standard of care strategy, as measured by number of patients registered for/treated by the CardioVascular Risk factor Management guideline.	—

Secondary

Measure	Time frame
Secondary study parameters and objectives (individual based): 1. To establish the diagnostic yield to diagnose obstructive CAD, for both strategies 2. To establish the effectiveness in terms of CAD diagnosis and exclusion of GP referral to the cardiologist for the calcium score cluster 3. To compare downstream diagnostic testing and treatment for both strategies as well as the time to (exclusion of) CAD diagnosis 4. To evaluate whether diagnostic stratification, in particular cut-offs for referral to the cardiologist, can be optimized for the calcium score 5. To estimate the effect of calcium scoring versus the standard of care on quality of life and cardiac complaints after 6, 12, and 24 months 6. To estimate the effect of calcium scoring on reduction of MACE (after 2 years). 7. To derive data on the costs per diagnosis of obstructive and diagnosis of non-obstructive CAD in the setting of calcium score testing versus the standard of care 8. To estimate the cost-utility of implementing the calcium score test in GP setting 9. To develop machine learning tools to evaluate big data on (combinations of) symptoms and family history/risk factors, and relationship to CAD 10. To establish and visualize relationship between (combinations of) symptoms and family history/risk factors and probability of CAD, using innovative techniques for big data analysis; these results will form the input for a risk assessment tool to be developed	—

Measure

Time frame

Secondary study parameters and objectives (individual based): 1. To establish the diagnostic yield to diagnose obstructive CAD, for both strategies 2. To establish the effectiveness in terms of CAD diagnosis and exclusion of GP referral to the cardiologist for the calcium score cluster 3. To compare downstream diagnostic testing and treatment for both strategies as well as the time to (exclusion of) CAD diagnosis 4. To evaluate whether diagnostic stratification, in particular cut-offs for referral to the cardiologist, can be optimized for the calcium score 5. To estimate the effect of calcium scoring versus the standard of care on quality of life and cardiac complaints after 6, 12, and 24 months 6. To estimate the effect of calcium scoring on reduction of MACE (after 2 years). 7. To derive data on the costs per diagnosis of obstructive and diagnosis of non-obstructive CAD in the setting of calcium score testing versus the standard of care 8. To estimate the cost-utility of implementing the calcium score test in GP setting 9. To develop machine learning tools to evaluate big data on (combinations of) symptoms and family history/risk factors, and relationship to CAD 10. To establish and visualize relationship between (combinations of) symptoms and family history/risk factors and probability of CAD, using innovative techniques for big data analysis; these results will form the input for a risk assessment tool to be developed

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026