Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm
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: 18F FAPI-42 PET/CT scan.
- Кому может быть актуально
- Состояния в реестре: Acute Myocardial Infarction, Ventricular Aneurysm Following Acute Myocardial Infarction, Myocardial Fibrosis. Базовые параметры: 18 лет — 75 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
- Китай
- 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
Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm
Обзор
The study will use 18F-FAPI PET/CT to study myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm (MI-VA). Participants will receive the PET/CT scan during hospital stay, as well as serial echocardiography and telephonic follow-ups. Analysed will focus on the characterization of myocardial fibrosis and its correlations with the clinical prognosis in the patients.
Подробное описание
The aim of this study is to investigate the temporal and spatial distribution of myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm using the novel fibroblast activation imaging tracer 18F FAPI-42 with PET/CT. This imaging modality allows for non-invasive visualization of activated fibroblasts, which are a key component of myocardial fibrotic remodeling after infarction.
The study is expected to enroll patients diagnosed with ventricular aneurysm secondary to acute myocardial infarction (AMI), who are hospitalized at Renji Hospital, Shanghai Jiao Tong University School of Medicine. The investigators expect to enroll 20 patients diagnosed with MI-VA and 10 AMI patients without evidence of ventricular aneurysm. With written informed consent, the investigators will review past medical records and document the medical history for each participant. During the hospital stay, participants will receive an 18F FAPI-42 PET/CT scan. FAPI uptake in the ventricular aneurysm and remote myocardium will be calculated as maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean). Correlation between SUVmax/SUVmean and critical markers of the disease progression, such as B-type natriuretic peptide (BNP) and cardiac troponin I (cTnI), will be analysed by Pearson or Spearman correlation coefficients. All participants will be followed for 1 year after enrolment, and serial echocardiography and telephonic follow-up will be performed. Major adverse cardiovascular events (MACE) will be recorded throughout the follow-up to reveal any predictive values of 18F-FAPI PET/C-assessed fibrosis for the patients with MI-VA.
Вмешательства
- Диагностический тест 18F FAPI-42 PET/CT scan
During the hospital stay, participants will receive an 18F FAPI-42 PET/CT scan. 18F FAPI-42 is a new fibroblast activation protein (FAP)-specific tracer used for fibrosis imaging. PET/CT will be performed using the ultra-high-resolution digital PET/CT uEXPLORER (United Imaging, Shanghai, China)
Первичные конечные точки
- FAPI uptake (SUV max) [Срок оценки: Day 1 after the PET/CT scan.]
- FAPI uptake (SUV mean) [Срок оценки: Day 1 after the PET/CT scan.]
Вторичные конечные точки (2)
- Cardiac function assessed by echocardiography [Срок оценки: Day 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-ups]
- The event rate of heart failure [Срок оценки: From date of enrollment until the date of follow-ups at 1 month, 6 month and 1 year post discharge.]
Критерии участия
Критерии включения
- Aged 18-75 years old
- Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
- Half male and half female
- Undergo CAG and PCI treatment;
- Receive either echocardiography or CMR to identify a ventricular aneurysm;
- Written informed consent
Критерии исключения
- Patients under the age of 18 years old;
- Patients who are pregnant/breastfeeding;
- Patients who has a previous history of allergy to radio tracers.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Renji Hospital — Шанхай
Идентификаторы
NCT: NCT06994221 · EARLY-MYO FAPI-PET/CT