Improved Management of Patients With Recent-Onset Stable Chest Pain
A Pragmatic, Cluster-randomised Stepped-wedge Trial to Evaluate the Effectiveness of a New Cross-sectoral Form of Care (NVF) in Patients With New-onset Stable Chest Pain and Suspected Coronary Artery Disease (CAD).
Philipps University Marburg
3,369 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
In Germany, coronary CT offers an accurate and less burdensome alternative to cardiac catheterisation for evaluating suspected coronary artery disease, but it is still underused. The IMPRO stepped-wedge trial tests a new, nationwide care model (NVF) in 16 regions to improve guideline-based intersectoral implementation of coronary CT and assess its impact on cardiovascular outcomes and healthcare costs. If effective, the model of care (NVF) could be adopted across Germany to enhance care quality while reducing unnecessary procedures and expenses.
Eligibility
Inclusion Criteria3
- Age ≥30 years
- Suspected CAD with stable chest pain
- Ability to give informed consent
Exclusion Criteria6
- Known or previously treated (with PCI or CABG) obstructive CAD (defined as at least one coronary diameter stenosis ≥50%)
- Acute coronary syndrome
- Negative invasive coronary angiography or coronary CT within the last 5 years
- Already enrolled in the study
- Not covered by statutory health insurance
- Unable to give consent
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Interventions
The intervention consists of structural and procedural components designed to improve cross-sectoral coordination in the diagnostic work-up of patients with suspected coronary artery disease (CAD). It builds upon the 2024 National Disease Management Guideline (NVL KHK 2024) and comprises three main components: (1) evidence-based initial assessment and indication for imaging diagnostics, (2) shared decision-making between primary care physicians, radiologists, and patients, and (3) quality-assured CT imaging and structured reporting in certified centres. Participating sites receive structured training, feedback, and centralized quality monitoring.
Locations(39)
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NCT07476040