Improved Management of Patients With Recent-Onset Stable Chest Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD). Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
Overview
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.
Interventions
- Behavioral IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics
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-assure
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Germany · 39 centers
- Universitätsklinikum Augsburg, Diagnostische und Interventionelle Radiologie und Neuroradi — Augsburg
- Universitätsklinikum Augsburg, Institut für Allgemeinmedizin — Augsburg
- RHOEN-Klinikum AG, Campus Bad Neustadt, Klinik für Radiologie — Bad Neustadt an der Saale
- Charité-Universitätsmedizin Berlin, Institut für Allgemeinmedizin — Berlin
- Charité - Universitätsmedizin Berlin, Klinik für Radiologie — Berlin
- Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie — Cologne
- Universitätsklinikum Köln, Institut für Allgemeinmedizin — Cologne
- Universitätsklinikum Düsseldorf, Institut für Allgemeinmedizin (ifam) — Düsseldorf
- … and 31 more centers
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. PMID 38664649
- DISCHARGE 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 PMID 35240010
- Dewey 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 27777234
Identifiers
NCT: NCT07476040 · 01NVF24302