NCT07476040

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).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,369 (estimated)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
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-assured CT imaging and structured reporting in certified centres. Participating sites receive structured training, feedback, and centralized quality monitoring.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-17
• Last updated: 2026-04-07

Locations

39 sites across 1 country: Germany