Coronary Artery Disease (CAD)IMPRONCT07476040
Improved Management of Patients With Recent-Onset Stable Chest Pain
A study testing IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics in people with Coronary Artery Disease (CAD), run by Philipps University Marburg at 39 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,369 participants
- Where
- 39 sitesGermany
- Study dates
- 1 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥30 years
- Suspected CAD with stable chest pain
- Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marc Dewey, Prof. Dr. contact
39 sites in 1 country
Germany39 sites, 39 recruiting
- Recruiting
Universitätsklinikum Augsburg, Diagnostische und Interventionelle Radiologie und Neuroradiologie
Augsburg, 86156
Josua Decker, Dr., +49 821 400-01, josua.decker@uk-augsburg.de
- Recruiting
Universitätsklinikum Augsburg, Institut für Allgemeinmedizin
Augsburg, 86156
Marco Roos, Prof. Dr., +49 8214009560, marco.roos@med.uni-augsburg.de
- Recruiting
RHOEN-Klinikum AG, Campus Bad Neustadt, Klinik für Radiologie
Bad Neustadt an der Saale, 97616
Lukas Lehmkuhl, PD Dr., +49 97716623901, lukas.lemkuhl@campus-nes.de
- Recruiting
Charité-Universitätsmedizin Berlin, Institut für Allgemeinmedizin
Berlin, 10098
Christoph Heintze, Prof. Dr., +49 30450514226, christoph.heintze@charite.de
- Recruiting
Charité - Universitätsmedizin Berlin, Klinik für Radiologie
Berlin, 10117
Federico Biavati, +49 30 450 627 309, federico.biavati@charite.de
Patrick Asbach, Prof. Dr., +49 30 450 527510, patrick.asbach@charite.de
- Recruiting
Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie
Cologne, 50937
David Maintz, Prof. Dr., +49 221 478-82035, david.maintz@uk-koeln.de
- Recruiting
Universitätsklinikum Köln, Institut für Allgemeinmedizin
Cologne, 50937
Beate Müller, Prof. Dr., +49 22147832170, beate.mueller@uk-koeln.de
- Recruiting
Universitätsklinikum Düsseldorf, Institut für Allgemeinmedizin (ifam)
Düsseldorf, 40225
Stefan Wilm, Prof. Dr., +49 (0)211 / 81- 1 77 71, stefan.wilm@med.uni-duesseldorf.de
- Recruiting
Universitätsklinikum Düsseldorf, Institut für Diagnostische und Interventionelle Radiologie
Düsseldorf, 40225
Gerald Antoch, Prof. Dr., +49 (0) 211 - 81 17752, Antoch@med.uni-duesseldorf.de
- Recruiting
Röntgeninstitut
Düsseldorf, 40476
Philipp Begemann, PD Dr., +49 211 49669 1000, p.begemann@roentgeninstitut.de
- Recruiting
Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut
Erlangen, 91054
Thomas Kühlein, Prof. Dr., +49 91318531140, allgemeinmedizin@uk-erlangen.de
- Recruiting
Universitätsklinikum Erlangen, Radiologisches Institut
Erlangen, 91054
Michael Uder, Prof. Dr., +49 91318536065, Michael.Uder@uk-erlangen.de
- Recruiting
Goethe-Universität Frankfurt am Main, Institut für Allgemeinmedizin
Frankfurt, 60590
Karola Mergenthal, Dr., +49 6963014149, mergenthal@allgemeinmedizin.uni-frankfurt.de
- Recruiting
Universitätsklinikum Gießen, Diagnostische und Interventionelle Radiologie und Kinderradiologie
Giessen, 35392
Gabriele Krombach, Prof. Dr., +49 641 985-41801, gabriele.krombach@uniklinikum-giessen.de
- Recruiting
Universitätsmedizin Göttingen, Institut für Allgemeinmedizin
Göttingen, 37073
Eva Hummers, Prof. Dr., +49 5513968193, eva.hummers@med.uni-goettingen.de
- Recruiting
Georg-August-Universität Göttingen, Universitätsmedizin, Institut für Diagnostische und Interventionelle Radiologie
Göttingen, 37075
Joachim Lotz, Prof. Dr., +49 5513968966, joachim.lotz@med.uni-goettingen.de
- Recruiting
Universitätsmedizin Greifswald, Institut für Community Medicine, Abt. Allgemeinmedizin
Greifswald, 17475
Jean-Francois Chenot, Prof. Dr., +49 38348622282, jchenot@uni-greifswald.de
- Recruiting
Radiologische Allianz Hamburg
Hamburg, 20095
Claas Philip Nähle, Prof. Dr., +49 40325552141, naehle@radiologische-allianz.de
- Recruiting
Universitätsklinikum Hamburg-Eppendorf, Institut und Poliklinik für Allgemeinmedizin
Hamburg, 20246
Martin Scherer, Prof. Dr., +49 40741052400, m.scherer@uke.de
- Recruiting
Institut für Allgemeinmedizin des Universitätsklinikums Jena
Jena, 07743
Jutta Bleidorn, Prof. Dr., +49 3641/9-395800, Jutta.Bleidorn@med.uni-jena.de
- Recruiting
Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie
Jena, 07747
Sebastian Reinartz, Prof. Dr., +49 3641 9-324831, sebastian.reinartz@med.uni-jena.de
- Recruiting
Christian-Albrechts-Universität zu Kiel, Medizinische Fakultät, Institut für Allgemeinmedizin
Kiel, 24105
Hanna Kaduszckiewicz, Prof. Dr., +49 43150030101, kaduszkiewicz@allgemeinmedizin.uni-kiel.de
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Radiologie und Neuroradiologie
Kiel, 24105
Marcus Both, Prof. Dr., 0431 500-16502, Marcus.Both@uksh.de
- Recruiting
Universität Leipzig, Institut für Allgemeinmedizin
Leipzig, 04103
Stefan Lippmann, Dr., +49 3419715735, Stefan.Lippmann@medizin.uni-leipzig.de
- Recruiting
Universitätsklinikum Leipzig, Institut für Diagnostische und Interventionelle Radiologie
Leipzig, 04103
Timm Denecke, Prof. Dr., +49 3419717402, Timm.Denecke@medizin.uni-leipzig.de
- Recruiting
Herzzentrum Leipzig, Abteilung für Diagnostische und Interventionelle Radiologie
Leipzig, 04289
Matthias Gutberlet, Prof. Dr., +49 3418651702, Matthias.gutberlet@helios-gesundtheit.de
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Allgemeinmedizin
Lübeck, 23538
Jost Steinhäuser, Prof. Dr., +49 45131018000, jost.steinhäuser@uksh.de
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Institut für Radiologie und Nuklearmedizin
Lübeck, 23538
Jörg Barkhausen, Prof. Dr., +49 45150017000, joerg.barkhausen@uksh.de
- Recruiting
Philipps University Marburg, Institut für Allgemeinmedizin
Marburg, 35043
Annika Viniol, Prof. Dr., +4964212865120, annika.viniol@staff.uni-marburg.de
- Recruiting
Universitätsmedizin Rostock, Institut für Allgemeinmedizin
Rostock, 18057
Ralf Michael Jendyk, Prof. Dr., +49 381 4942480, ralf.jendyk@med.uni-rostock.de
- Recruiting
Universitätsmedizin Rostock, Institut für Diagnostische und Interventionelle Radiologie, Kinder- und Neuroradiologie
Rostock, 18057
Felix Meinel, Prof. Dr., +49 3814949275, felix.meinel@med.uni-rostock.de
- Recruiting
Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie, Department für Radiologie
Tübingen, 72076
Konstantin Nikolaou, Prof. Dr., +49 70712982087, Konstantin.Nikolaou@med.uni-tuebingen.de
- Recruiting
Universitätsklinikum Tübingen, Institut für Allgemeinmedizin & Interprofessionelle Versorgung
Tübingen, 72076
Stefanie Joos, Prof. Dr., +49 7071 29-85213, stefanie.joos@med.uni-tuebingen.de
- Recruiting
Universitätsklinikum Ulm, Institut für Allgemeinmedizin
Ulm, 89081
Anne Barzel, Prof. Dr., +49 73150057901, anne.barzel@uni-ulm.de
- Recruiting
Universitätsklinikum Ulm, Klinik für Diagnostische und Interventionelle Radiologie
Ulm, 89081
Meinrad Beer, Prof. Dr., +49 73150061001, meinrad.beer@uniklinik-ulm.de
- Recruiting
radiomed Gemeinschaftspraxis für Radiologie und Nuklearmedizin
Wiesbaden, 65185
Stefanie Bitschnau, Dr., +49 61190017117, bitschnau@radiomed-praxis.de
- Recruiting
RNS Gemeinschaftspraxis für Radiologie und Strahlentherapie
Wiesbaden, 65189
Ralf Bauer, Prof. Dr., +49 611 - 56589-1400, ralfwbauer@aol.com
- Recruiting
Universität Würzburg, Institut für Allgemeinmedizin
Würzburg, 97080
Ildikó Gágyor, Prof. Dr., +49 931-201-47802, gagyor_i@ukw.de
- Recruiting
Universitätsklinkum Würzburg, Institut für Diagnostische und Interventionelle Radiologie
Würzburg, 97080
Thorsten Bley, Prof. Dr., +49 93120134001, Bley_T@ukw.de
About this study
Official title: 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).
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.
Read the detailed description
In Germany, more than 700,000 patients with chest pain undergo cardiac catheterisation each year. The most common reason is suspected coronary artery disease-the leading cause of death worldwide. Proportionally, more cardiac catheterizations are performed in Germany than in any other country. Coronary computed tomography (coronary CT) is available as an alternative diagnostic method to cardiac catheterization. The advantages of coronary CT include a lower complication rate, greater accuracy in detecting deposits in the coronary arteries, reduced burden for patients, and less procedural effort.
The aim of the partners in the IMPRO project is to optimize the implementation of coronary CT in routine clinical care following the resolution of the Federal Joint Committee on January 18, 2024, while at the same time avoiding overuse. For this purpose, a new model of care will be tested in 16 different regions across 12 federal states in Germany. This model is intended to improve primary and cross-sectoral care for patients with suspected coronary artery disease. The primary goal of the nationwide study is to determine whether the new model of care helps reduce cardiovascular events, such as heart attacks and strokes, in patients with suspected coronary artery disease. The researchers will also analyze how patients respond to this type of treatment and whether it leads to cost savings. The project is funded for 39 months with a total of approximately 9.3 million euros.
If successful, the new model of care could be implemented nationwide to improve the treatment of patients with suspected coronary artery disease and to avoid unnecessary costs for the healthcare system.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics
- Keywords
- Coronary Heart Disease, Coronary Angiography, Percutaneous Coronary Intervention, Evidence-Based Practice, Shared Decision Making, Health Care Quality Assurance, Coronary Artery Disease (CAD), computed tomography, stepped-wedge trial, health services research
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPRO - Cross-Sectoral Care Model for Coronary DiagnosticsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual 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 | Experimental | Participants 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. Receives: Behavioral: IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite endpoint: Major Adverse Cardiovascular Events (MACE) including cardiovascular death, myocardial infarction, stroke, and procedure-related complications from diagnostic testing and subsequent management/therapy in the two randomization groups. Procedure-related complications (major and minor) are defined in the subsequent outcome measure and include events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures.
Measured: From enrolment to 12 months for primary MACE analysis in the G-BA-funded IMPRO trial; extended follow-up to 5 years for MACE (cardiovascular death, myocardial infarction, stroke) excluding procedure-related complications; data at 3, 12 months and 5 years
Secondary outcomes (20)
Prospective Primary Safety Endpoint: Procedure-related Complications
Rate of procedure-related complications by diagnostic imaging modality and by interventional/surgical treatments (PCI, CABG). Includes major and minor complications. Major complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures, including death, nonfatal myocardial infarction, nonfatal stroke, complications prolonging hospitalization ≥24 hours, coronary/aortic dissection, cardiogenic shock, cardiac tamponade, retroperitoneal bleeding, cardiac arrhythmia (ventricular tachycardia/fibrillation), or cardiac arrest. Minor complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures not meeting major criteria, including hematoma or secondary bleeding at the puncture site, bradycardia, angina pectoris without myocardial infarction, allergic reaction to contrast media, hypotension requiring treatment, infection, thrombosis, or arteriovenous fistula.
Measured: 3 months and 12 months
Indication quality
- Agreement of the diagnostic decision with the pre-test probability (PTP, below 15%, 15-50%, above 50% criterion) with the National Health Services guidelines for suspected coronary artery disease and the statistical distribution of PTP values across the scale (NVL KHK 2024), measured using the updated DISCHARGE PTP calculator in the two randomisation groups, 2) Agreement of the mean pre-test probability with the prevalence of obstructive coronary artery disease (CAD) defined as at least one at least 50% coronary artery diameter stenosis on coronary computed tomography angiography (CTA) and/or invasive coronary angiography (ICA) in the two randomisation groups.
Measured: From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)
Functional test rates
Rate of functional tests performed during the follow-up period (stress electrocardiography (ECG), cardiac stress magnetic resonance imaging (MRI), stress echocardiography, stress myocardial perfusion single-photon emission CT (SPECT), myocardial stress perfusion positron emission tomography (PET)) in the two randomisation groups.
Measured: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Revascularization rates
Rate of coronary artery revascularisations (percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)) performed during the follow-up period in the two randomisation groups.
Measured: 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
Rate of coronary CT performed during the follow-up period in the two randomisation groups.
Measured: 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
Rate of ICA procedures performed during the follow-up period in the two randomisation groups.
Measured: 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) results
Rate of diagnostic findings on the ICA procedures performed in the two randomisation groups (obstructive or non-obstructive CAD or no signs of CAD) to assess the yield of ICA defined as the proportion of ICAs performed in both randomisation groups demonstrating obstructive CAD.
Measured: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Coronary CT angiography (CTA) results
Rate of diagnostic findings on the CTA procedures performed in the two randomisation groups (obstructive or non-obstructive CAD or no signs of CAD) to assess the yield of CTA defined as the proportion of CTAs performed in both randomisation groups demonstrating obstructive CAD.
Measured: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Hospitalization due to chest pain
Rate of hospitalisations due to chest pain during the follow-up period in the two randomisation groups.
Measured: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Emergency department visits due to chest pain
Rate of emergency department visits due to chest pain during the follow-up period in the two randomisation groups.
Measured: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Assessability of coronary CTs
Proportion of non-diagnostic coronary CTs in the two randomisation groups.
Measured: From enrollment to 12 months (with follow-up data collection at 3 months, 12 months)
Radiation exposure
Estimated radiation exposure of cardiac imaging tests including coronary CT, ICA, SPECT, and PET in the two randomisation groups in millisieverts (mSv).
Measured: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Quality of life questionnaire
EQ-5D-5L: validated questionnaire with five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) in the two randomisation groups.
Measured: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Seattle Angina Questionnaire
SAQ-7 questionnaire (short version): disease-specific health status instrument for coronary artery disease (CAD) with seven items from the physical limitations, angina frequency, and quality of life domains in the two randomisation groups.
Measured: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Total medical care costs (Ct) from the statutory health insurance perspective
Cumulative healthcare costs that can be mapped from routine health insurance data.
Measured: 3 months, 6 months
Total medical care costs (Ct) from the perspective of society
Cumulative healthcare costs that can be mapped from primary data
Measured: 3 months, 12 months, 5 years
Cost-effectiveness ratio (ICER) based on routine data collected by health insurers
ΔCt/ΔMACE: The calculated total costs are compared with MACE (primary endpoint). The results are presented as the incremental cost-effectiveness ratio (ICER). Data sources are routine data and patient survey distributed by the health insurers.
Measured: 3 months, 6 months
Cost-effectiveness ratio (ICER) based on health care utilisation data
ΔCt/ΔMACE: The calculated total costs are compared with MACE (primary endpoint) in the two randomisation groups. The results are presented as the incremental cost-effectiveness ratio (ICER). Data source is primary health care utilisation data in the two randomisation groups.
Measured: 3 months, 12 months, 5 years
Cost-utility ratio (ICUR) based on routine data collected by health insurers
ΔCt/ΔQALYs: The calculated total costs are compared with quality of life (secondary endpoint), measured using the standardised and validated EQ-5D-5L. The results are presented as the incremental cost-utility ratio (ICUR). Data sources are routine data and patient survey distributed by health insurers.
Measured: 3 months and 6 months
Cost-utility ratio (ICUR) based on health care utilisation data
ΔCt/ΔQALYs: The calculated total costs are compared with quality of life (secondary endpoint), measured using the standardised and validated EQ-5D-5L. The results are presented as the incremental cost-utility ratio (ICUR). Data sources are primary data and patient quality of life survey in the two randomisation groups.
Measured: 3 months, 12 months, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study uses a stepped-wedge trial design in which clusters sequentially transition from a control phase to an intervention phase over a predefined period. The timing of each transition is randomised. Sixteen regional clusters in Germany, each comprising primary care networks and certified radiology departments, are allocated to four sequences. At each step, four clusters transition from control to intervention, until all clusters have implemented the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss
- Responsible party
- Sponsor
- Investigators
- Annika Viniol, Prof. Dr., Principal investigator, Philipps-Universität Marburg, Institut für Allgemeinmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476040
- Sponsor's protocol ID
- 01NVF24302
- Acronym
- IMPRO
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be performed through with the GUIDE-IT platform (Guide to Data Sharing of Imaging Trials, www.guideit.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))
Publications
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.
PubMed 38664649DISCHARGE 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.
PubMed 35240010Dewey 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.
PubMed 27777234
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07476040
- Acronym / sponsor ID
- IMPRO / 01NVF24302
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Coronary Heart Disease, Coronary Angiography, Percutaneous Coronary Intervention, Evidence-Based Practice, Shared Decision Making, Health Care Quality Assurance, Coronary Artery Disease (CAD), computed tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,369 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Germany, more than 700,000 patients with chest pain undergo cardiac catheterisation each year. The most common reason is suspected coronary artery disease-the leading cause of death worldwide. Proportionally, more cardiac catheterizations are performed in Germany than in any other country. Coronary computed tomography (coronary CT) is available as an alternative diagnostic method to cardiac catheterization. The advantages of coronary CT include a lower complication rate, greater accuracy in detecting deposits in the coronary arteries, reduced burden for patients, and less procedural effort.
The aim of the partners in the IMPRO project is to optimize the implementation of coronary CT in routine clinical care following the resolution of the Federal Joint Committee on January 18, 2024, while at the same time avoiding overuse. For this purpose, a new model of care will be tested in 16 different regions across 12 federal states in Germany. This model is intended to improve primary and cross-sectoral care for patients with suspected coronary artery disease. The primary goal of the nationwide study is to determine whether the new model of care helps reduce cardiovascular events, such as heart attacks and strokes, in patients with suspected coronary artery disease. The researchers will also analyze how patients respond to this type of treatment and whether it leads to cost savings. The project is funded for 39 months with a total of approximately 9.3 million euros.
If successful, the new model of care could be implemented nationwide to improve the treatment of patients with suspected coronary artery disease and to avoid unnecessary costs for the healthcare system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study uses a stepped-wedge trial design in which clusters sequentially transition from a control phase to an intervention phase over a predefined period. The timing of each transition is randomised. Sixteen regional clusters in Germany, each comprising primary care networks and certified radiology departments, are allocated to four sequences. At each step, four clusters transition from control to intervention, until all clusters have implemented the intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual 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 | Experimental | Behavioral: IMPRO - Cross-Sectoral Care Model for Coronary DiagnosticsParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥30 years
- Suspected CAD with stable chest pain
- Ability to give informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPRO - Cross-Sectoral Care Model for Coronary DiagnosticsThe 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. | Behavioural | IMPRO Program |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: From enrolment to 12 months for primary MACE analysis in the G-BA-funded IMPRO trial; extended follow-up to 5 years for MACE (cardiovascular death, myocardial infarction, stroke) excluding procedure-related complications; data at 3, 12 months and 5 years
Composite endpoint: Major Adverse Cardiovascular Events (MACE) including cardiovascular death, myocardial infarction, stroke, and procedure-related complications from diagnostic testing and subsequent management/therapy in the two randomization groups. Procedure-related complications (major and minor) are defined in the subsequent outcome measure and include events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures.
20 secondary outcomes
Prospective Primary Safety Endpoint: Procedure-related Complications
Time frame: 3 months and 12 months
Indication quality
Time frame: From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)
Functional test rates
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Revascularization rates
Time frame: 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
Time frame: 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
Time frame: 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) results
Time frame: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Coronary CT angiography (CTA) results
Time frame: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Hospitalization due to chest pain
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Emergency department visits due to chest pain
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Assessability of coronary CTs
Time frame: From enrollment to 12 months (with follow-up data collection at 3 months, 12 months)
Radiation exposure
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Quality of life questionnaire
Time frame: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Seattle Angina Questionnaire
Time frame: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Total medical care costs (Ct) from the statutory health insurance perspective
Time frame: 3 months, 6 months
Total medical care costs (Ct) from the perspective of society
Time frame: 3 months, 12 months, 5 years
Cost-effectiveness ratio (ICER) based on routine data collected by health insurers
Time frame: 3 months, 6 months
Cost-effectiveness ratio (ICER) based on health care utilisation data
Time frame: 3 months, 12 months, 5 years
Cost-utility ratio (ICUR) based on routine data collected by health insurers
Time frame: 3 months and 6 months
Cost-utility ratio (ICUR) based on health care utilisation data
Time frame: 3 months, 12 months, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 38664649Jung-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.
- Background: PubMed 35240010DISCHARGE 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.
- Background: PubMed 27777234Dewey 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.
- IMPRO - Innovatives Management für Patientinnen und Patienten mit erstmals aufgetretenen stabilen ThoraxschmerzenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data sharing will be performed through with the GUIDE-IT platform (Guide to Data Sharing of Imaging Trials, www.guideit.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))
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Dewey, Prof. Dr. contact
Annika Viniol, Prof. Dr. principal investigator
Philipps-Universität Marburg, Institut für Allgemeinmedizin
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics in people with Coronary Artery Disease (CAD), run by Philipps University Marburg at 39 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annika Viniol, Prof. Dr. (+49 6421 28-65120, annika.viniol@staff.uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: From enrolment to 12 months for primary MACE analysis in the G-BA-funded IMPRO trial; extended follow-up to 5 years for MACE (cardiovascular death, myocardial infarction, stroke) excluding procedure-related complications; data at 3, 12 months and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.