Improved Management of Patients With Recent-Onset Stable Chest Pain
IMPRO
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).
1 other identifier
interventional
3,369
1 country
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
March 17, 2026
March 1, 2026
1.9 years
March 10, 2026
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiovascular Events (MACE)
Composite Endpoint: Major Adverse Cardiovascular Events (MACE) consisting of the following components: cardiovascular death, myocardial infarction, stroke, procedure related complications from diagnostic testing and subsequent management and therapy in the two randomisation groups.
From enrollment to 12 months as the primary time frame for MACE and in the extended long-term follow-up analysis after 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Secondary Outcomes (18)
Indication quality
From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)
Functional test rates
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Revascularization rates
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Coronary CT angiography (CTA) rates
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Invasive coronary angiography (ICA) rates
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
- +13 more secondary outcomes
Other Outcomes (59)
Comparison of incidental findings in Computed Tomography Angiography between the control and intervention phase, and potential benefits and harms of findings Analysis of prevalence non-coronary cardiac and non-cardiac causes of symptoms.
3 months, 12 months, 5 years
Comparison of incidental findings in control and intervention phase, and potential benefits and harms of findings: Influence of non-coronary cardiac and non-cardiac findings on Major Adverse Cardiac Events, non-cardiac events and Quality of Life.
3 months, 12 months, 5 years
Comparison of incidental findings in control and intervention phase, and potential benefits and harms of findings: Rate for malignancy in nodules seen on Computed Tomography Angiography.
3 months, 12 months, 5 years
- +56 more other outcomes
Study Arms (2)
Usual Care
NO INTERVENTIONUsual diagnostic and treatment procedures for suspected coronary artery disease according to national guideline (NVL KHK 2024), without structured cross-sectoral coordination or quality feedback.
IMPRO Program
EXPERIMENTALParticipants in this arm will receive the IMPRO cross-sectoral care model (NVF) for patients presenting with stable chest pain and suspected coronary artery disease (CAD). The program integrates general practitioners and certified cardiac CT centres to improve diagnostic indication, shared decision-making, and reporting quality.
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.
Eligibility Criteria
You may qualify if:
- Age ≥30 years
- Suspected CAD with stable chest pain
- Ability to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philipps University Marburglead
- Gemeinsamer Bundesausschuss (GBA)collaborator
Study Sites (39)
Universitätsklinikum Augsburg, Diagnostische und Interventionelle Radiologie und Neuroradiologie
Augsburg, 86156, Germany
Universitätsklinikum Augsburg, Institut für Allgemeinmedizin
Augsburg, 86156, Germany
RHOEN-Klinikum AG, Campus Bad Neustadt, Klinik für Radiologie
Bad Neustadt an der Saale, 97616, Germany
Charité-Universitätsmedizin Berlin, Institut für Allgemeinmedizin
Berlin, 10098, Germany
Charité - Universitätsmedizin Berlin, Klinik für Radiologie
Berlin, 10117, Germany
Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie
Cologne, 50937, Germany
Universitätsklinikum Köln, Institut für Allgemeinmedizin
Cologne, 50937, Germany
Universitätsklinikum Düsseldorf, Institut für Allgemeinmedizin (ifam)
Düsseldorf, 40225, Germany
Universitätsklinikum Düsseldorf, Institut für Diagnostische und Interventionelle Radiologie
Düsseldorf, 40225, Germany
Röntgeninstitut
Düsseldorf, 40476, Germany
Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut
Erlangen, 91054, Germany
Universitätsklinikum Erlangen, Radiologisches Institut
Erlangen, 91054, Germany
Goethe-Universität Frankfurt am Main, Institut für Allgemeinmedizin
Frankfurt, 60590, Germany
Universitätsklinikum Gießen, Diagnostische und Interventionelle Radiologie und Kinderradiologie
Giessen, 35392, Germany
Universitätsmedizin Göttingen, Institut für Allgemeinmedizin
Göttingen, 37073, Germany
Georg-August-Universität Göttingen, Universitätsmedizin, Institut für Diagnostische und Interventionelle Radiologie
Göttingen, 37075, Germany
Universitätsmedizin Greifswald, Institut für Community Medicine, Abt. Allgemeinmedizin
Greifswald, 17475, Germany
Radiologische Allianz Hamburg
Hamburg, 20095, Germany
Universitätsklinikum Hamburg-Eppendorf, Institut und Poliklinik für Allgemeinmedizin
Hamburg, 20246, Germany
Institut für Allgemeinmedizin des Universitätsklinikums Jena
Jena, 07743, Germany
Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie
Jena, 07747, Germany
Christian-Albrechts-Universität zu Kiel, Medizinische Fakultät, Institut für Allgemeinmedizin
Kiel, 24105, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Radiologie und Neuroradiologie
Kiel, 24105, Germany
Universität Leipzig, Institut für Allgemeinmedizin
Leipzig, 04103, Germany
Universitätsklinikum Leipzig, Institut für Diagnostische und Interventionelle Radiologie
Leipzig, 04103, Germany
Herzzentrum Leipzig, Abteilung für Diagnostische und Interventionelle Radiologie
Leipzig, 04289, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Allgemeinmedizin
Lübeck, 23538, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Radiologie und Nuklearmedizin
Lübeck, 23538, Germany
Philipps University Marburg, Institut für Allgemeinmedizin
Marburg, 35043, Germany
Universitätsmedizin Rostock, Institut für Allgemeinmedizin
Rostock, 18057, Germany
Universitätsmedizin Rostock, Institut für Diagnostische und Interventionelle Radiologie, Kinder- und Neuroradiologie
Rostock, 18057, Germany
Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie, Department für Radiologie
Tübingen, 72076, Germany
Universitätsklinikum Tübingen, Institut für Allgemeinmedizin & Interprofessionelle Versorgung
Tübingen, 72076, Germany
Universitätsklinikum Ulm, Institut für Allgemeinmedizin
Ulm, 89081, Germany
Universitätsklinikum Ulm, Klinik für Diagnostische und Interventionelle Radiologie
Ulm, 89081, Germany
radiomed Gemeinschaftspraxis für Radiologie und Nuklearmedizin
Wiesbaden, 65185, Germany
RNS Gemeinschaftspraxis für Radiologie und Strahlentherapie
Wiesbaden, 65189, Germany
Universität Würzburg, Institut für Allgemeinmedizin
Würzburg, 97080, Germany
Universitätsklinkum Würzburg, Institut für Diagnostische und Interventionelle Radiologie
Würzburg, 97080, Germany
Related Publications (3)
Jung-Henrich J, Schlossler K, Uebel T, Chikhradze N, Suslow A, Lindner N, Fahrenkrog S, Kraft J, Hummers E, Vollmar HC, Gagyor I, Heider D, Konig HH, Donner-Banzhoff N. Development and implementation of a treatment pathway to reduce coronary angiograms - lessons from a failure. BMC Health Serv Res. 2024 Apr 25;24(1):527. doi: 10.1186/s12913-024-10904-5.
PMID: 38664649BACKGROUNDDISCHARGE Trial Group; Maurovich-Horvat P, Bosserdt M, Kofoed KF, Rieckmann N, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Cemerlic Adic N, Gutberlet M, Dodd JD, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Kubiak C, Gutierrez-Ibarluzea I, Schultz Hansen K, Muller-Nordhorn J, Merkely B, Knudsen AD, Benedek I, Orr C, Xavier Valente F, Zvaigzne L, Suchanek V, Zajanckauskiene L, Adic F, Woinke M, Hensey M, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Mancone M, Kusmierz D, Feuchtner G, Pietila M, Gama Ribeiro V, Drosch T, Delles C, Matta G, Fisher M, Szilveszter B, Larsen L, Ratiu M, Kelly S, Garcia Del Blanco B, Rubio A, Drobni ZD, Jurlander B, Rodean I, Regan S, Cuellar Calabria H, Boussoussou M, Engstrom T, Hodas R, Napp AE, Haase R, Feger S, Serna-Higuita LM, Neumann K, Dreger H, Rief M, Wieske V, Estrella M, Martus P, Dewey M. CT or Invasive Coronary Angiography in Stable Chest Pain. N Engl J Med. 2022 Apr 28;386(17):1591-1602. doi: 10.1056/NEJMoa2200963. Epub 2022 Mar 4.
PMID: 35240010BACKGROUNDDewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.
PMID: 27777234BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annika Viniol, Prof. Dr.
Philipps-Universität Marburg, Institut für Allgemeinmedizin
Central Study Contacts
Marc Dewey, Prof. Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the stepped-wedge trial health services intervention, participants and care providers are not blinded. Primary outcome events (MACE) are adjudicated by an independent, blinded Clinical Events Committee (CEC) based on anonymised documentation
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 17, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared after completion of the IMPRO study for a maximum period of 30 years.
- Access Criteria
- Access to pseudonymized data will only be granted to those who submit an application to the dissemination committee (members of the consortium leadership of the participating studies). The provided pseudonymized data comprise both clinical data, including clinical endpoints at 3 and 12 months as well as at 5 years, and imaging data (cardiac CT scans in DICOM format). The study proposal must include: The proposed study's overview, rationale, aims and analysis methods, plans for dissemination of results and names of those wishing to access data, and how is the data going to be stored and for how long.
Data sharing will be performed through with the GUIDE-IT platform (Guide to Data Sharing of Imaging Trials, www.guide-it.org), which will allow access for researcher according to the GUIDE-IT data sharing rules and governance as well as application processes. After completion of the study, pseudonymised data will be made available for scientific reuse. This will comprise clinical data, including clinical endpoints at 3 and 12 months as well as 5 years, and imaging data (cardiac CT scans in DICOM format). Specifically: * Demographic data: age category, gender, weight, height. * Health data: Clinical data (diagnoses, medical history, physical examinations, vital signs, concomitant medication, laboratory parameters, cardiological parameters: ECG, etc.) * Image data: Computed tomography scans * Questionnaire data (quality of life (EQ-5-DL), angina (SAQ-7))