Improved Management of Patients With Recent-Onset Stable Chest Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics.
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Disease (CAD). Базовые параметры: от 30 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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).
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Major Adverse Cardiovascular Events (MACE) [Срок оценки: 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]
Вторичные конечные точки (12)
- Prospective Primary Safety Endpoint: Procedure-related Complications [Срок оценки: 3 months and 12 months]
- Indication quality [Срок оценки: From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)]
- Functional test rates [Срок оценки: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)]
- Revascularization rates [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to 12 months (with follow-up data collection at 3 months, 12 months)]
- Radiation exposure [Срок оценки: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)]
Критерии участия
Критерии включения
- Age ≥30 years
- Suspected CAD with stable chest pain
- Ability to give informed consent
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Диагностика
Центры проведения
Германия · 39 центров
- 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
- … и ещё 31 центр
Публикации
- 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
Идентификаторы
NCT: NCT07476040 · 01NVF24302