Better care for people 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).
This project will test a new nationwide care model that uses coronary CT instead of routine cardiac catheterization for adults 30 and older with recent-onset stable chest pain to see if it lowers heart attacks, strokes, and healthcare costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3369 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Philipps University Marburg Academic / other |
| Locations | 39 sites (Augsburg and 38 other locations) |
| Trial ID | NCT07476040 on ClinicalTrials.gov |
What this trial studies
IMPRO is a stepped-wedge interventional implementation trial testing a new cross-sectoral care model (NVF) across 16 regions in 12 German federal states to increase guideline-based use of coronary CT for suspected coronary artery disease. The model aims to improve primary and cross-sectoral pathways so eligible patients with recent-onset stable chest pain can receive coronary CT as a less invasive diagnostic alternative to routine cardiac catheterisation. The trial will compare cardiovascular events, patient responses, and healthcare costs before and after NVF rollout, excluding patients with known obstructive CAD, recent negative coronary imaging, or acute coronary syndrome. The project is funded for 39 months with roughly €9.3 million in support.
Who should consider this trial
Good fit: Adults aged 30 or older with suspected coronary artery disease and recent-onset stable chest pain who can give informed consent and are covered by statutory health insurance are the ideal candidates.
Not a fit: Patients with known or previously treated obstructive CAD, recent negative invasive angiography or coronary CT, acute coronary syndrome, lack of statutory health insurance, or inability to consent are unlikely to receive benefit from this care model.
Why it matters
Potential benefit: If successful, the NVF model could reduce unnecessary invasive catheterisations, lower procedure-related complications, prevent cardiovascular events, and save healthcare costs.
How similar studies have performed: Large trials such as SCOT-HEART and PROMISE have shown coronary CT is an accurate, less invasive diagnostic alternative that can change management, so the diagnostic approach is evidence-based though this nationwide implementation model is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥30 years * Suspected CAD with stable chest pain * Ability to give informed consent Exclusion Criteria: * 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
Where this trial is running
Augsburg and 38 other locations
- Universitätsklinikum Augsburg, Diagnostische und Interventionelle Radiologie und Neuroradiologie — Augsburg, Germany (Recruiting)
- Universitätsklinikum Augsburg, Institut für Allgemeinmedizin — Augsburg, Germany (Recruiting)
- RHOEN-Klinikum AG, Campus Bad Neustadt, Klinik für Radiologie — Bad Neustadt an der Saale, Germany (Recruiting)
- Charité-Universitätsmedizin Berlin, Institut für Allgemeinmedizin — Berlin, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin, Klinik für Radiologie — Berlin, Germany (Recruiting)
- Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie — Cologne, Germany (Recruiting)
- Universitätsklinikum Köln, Institut für Allgemeinmedizin — Cologne, Germany (Recruiting)
- Universitätsklinikum Düsseldorf, Institut für Allgemeinmedizin (ifam) — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Düsseldorf, Institut für Diagnostische und Interventionelle Radiologie — Düsseldorf, Germany (Recruiting)
- Röntgeninstitut — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut — Erlangen, Germany (Recruiting)
- Universitätsklinikum Erlangen, Radiologisches Institut — Erlangen, Germany (Recruiting)
- Goethe-Universität Frankfurt am Main, Institut für Allgemeinmedizin — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Gießen, Diagnostische und Interventionelle Radiologie und Kinderradiologie — Giessen, Germany (Recruiting)
- Universitätsmedizin Göttingen, Institut für Allgemeinmedizin — Göttingen, Germany (Recruiting)
- Georg-August-Universität Göttingen, Universitätsmedizin, Institut für Diagnostische und Interventionelle Radiologie — Göttingen, Germany (Recruiting)
- Universitätsmedizin Greifswald, Institut für Community Medicine, Abt. Allgemeinmedizin — Greifswald, Germany (Recruiting)
- Radiologische Allianz Hamburg — Hamburg, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf, Institut und Poliklinik für Allgemeinmedizin — Hamburg, Germany (Recruiting)
- Institut für Allgemeinmedizin des Universitätsklinikums Jena — Jena, Germany (Recruiting)
- Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie — Jena, Germany (Recruiting)
- Christian-Albrechts-Universität zu Kiel, Medizinische Fakultät, Institut für Allgemeinmedizin — Kiel, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Radiologie und Neuroradiologie — Kiel, Germany (Recruiting)
- Universität Leipzig, Institut für Allgemeinmedizin — Leipzig, Germany (Recruiting)
- Universitätsklinikum Leipzig, Institut für Diagnostische und Interventionelle Radiologie — Leipzig, Germany (Recruiting)
- Herzzentrum Leipzig, Abteilung für Diagnostische und Interventionelle Radiologie — Leipzig, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Allgemeinmedizin — Lübeck, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Radiologie und Nuklearmedizin — Lübeck, Germany (Recruiting)
- Philipps University Marburg, Institut für Allgemeinmedizin — Marburg, Germany (Recruiting)
- Universitätsmedizin Rostock, Institut für Allgemeinmedizin — Rostock, Germany (Recruiting)
- Universitätsmedizin Rostock, Institut für Diagnostische und Interventionelle Radiologie, Kinder- und Neuroradiologie — Rostock, Germany (Recruiting)
- Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie, Department für Radiologie — Tübingen, Germany (Recruiting)
- Universitätsklinikum Tübingen, Institut für Allgemeinmedizin & Interprofessionelle Versorgung — Tübingen, Germany (Recruiting)
- Universitätsklinikum Ulm, Institut für Allgemeinmedizin — Ulm, Germany (Recruiting)
- Universitätsklinikum Ulm, Klinik für Diagnostische und Interventionelle Radiologie — Ulm, Germany (Recruiting)
- radiomed Gemeinschaftspraxis für Radiologie und Nuklearmedizin — Wiesbaden, Germany (Recruiting)
- RNS Gemeinschaftspraxis für Radiologie und Strahlentherapie — Wiesbaden, Germany (Recruiting)
- Universität Würzburg, Institut für Allgemeinmedizin — Würzburg, Germany (Recruiting)
- Universitätsklinkum Würzburg, Institut für Diagnostische und Interventionelle Radiologie — Würzburg, Germany (Recruiting)
Study contacts
- Principal investigator: Annika Viniol, Prof. Dr. — Philipps-Universität Marburg, Institut für Allgemeinmedizin
- Study coordinator: Annika Viniol, Prof. Dr.
- Email: annika.viniol@staff.uni-marburg.de
- Phone: +49 6421 28-65120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.