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).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,369
- 试验地点
- 39
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥30 years
- •Suspected CAD with stable chest pain
- •Ability to give informed consent
排除标准
- •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
研究组 & 干预措施
Usual Care
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
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.
干预措施: IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics (Behavioral)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 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)
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.
次要结局
- 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))
- Coronary angiography results(From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years))
- Hospitalization due to chest pain(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(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(From enrollment to 12 months (with follow-up data collection at 3 months, 12 months))
- Radiation exposure(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(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(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(3 months, 6 months)
- Total medical care costs (Ct) from the perspective of society(3 months, 12 months, 5 years)
- Cost-effectiveness ratio (ICER)(3 months, 6 months)
- Cost-effectiveness ratio (ICER)(3 months, 12 months, 5 years)
- Cost-utility ratio (ICUR)(3 months and 6 months)
- Cost-utility ratio (ICUR)(3 months, 12 months, 5 years)