OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Myocardial Infarction, Myocardial Ischemia, STEMI, NSTEMI. Базовые параметры: от 18 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.
Подробное описание
* To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI)
1. Periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest including: new AMI, unstable angina (UA), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * To describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with AMI during the afore mentioned period * To study the impact of different devices and strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI * To describe early and late angiographic and OCT-findings among coronary artery disease in patients with AMI treated with various metallic stent and scaffold devices * To assess possible predictors for coronary stent implantation or device failure * To evaluate the impact of different antithrombotic regimens on patient clinical outcomes * To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices. * To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.
Первичные конечные точки
- Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year [Срок оценки: at 1 year]
Вторичные конечные точки (12)
- Rate of major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: 1, 2, 5 and 10 years]
- Rate of new AMI [Срок оценки: 1, 2, 5 and 10 years]
- Rate of TIA or stroke [Срок оценки: 1, 2, 5 and 10 years]
- Rate of stent thrombosis [Срок оценки: 1, 2, 5 and 10 years]
- Rate of target vessel revascularization [Срок оценки: 1, 2, 5 and 10 years]
- Rate of target lesion failure [Срок оценки: 1, 2, 5 and 10 years]
- Rate of ischemia-driven revascularization [Срок оценки: 1, 2, 5 and 10 years]
- Rate of unstable angina [Срок оценки: 1, 2, 5 and 10 years]
- Rate of rehospitalization for recurrent angina [Срок оценки: 1, 2, 5 and 10 years]
- Rate of hospitalization for heart failure [Срок оценки: 1, 2, 5 and 10 years]
- Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up. [Срок оценки: 1, 2, 5 and 10 years]
- Rate of cardiovascular mortality [Срок оценки: 1, 2, 5 and 10 years]
Критерии участия
Критерии включения
- Subject >18 years of age
- Individuals who are newly diagnosed with AMI or have been diagnosed with AMI (STEMI or NSTEMI) within the last 5 years (since 2016).
- Subjects must be willing to sign a patient informed consent (PIC) OR a patient ́s relative/ proxy are willing to provide PIC or patients have signed the General Consent (GK).
Критерии исключения
- Patient unwilling or unable to provide informed consent
- Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- Luzerner Heart Centre — Lucerne
Публикации
- Tersalvi G, Attinger-Toller A, Kalathil D, Winterton D, Cioffi GM, Madanchi M, Seiler T, Stadelmann M, Goffredo F, Fankhauser P, Moccetti F, Wolfrum M, Toggweiler S, Bloch A, Kobza R, Cuculi F, Bossard M. Trajectories of Cardiac Function Following Treatment With an Impella Device in Patients With Acute Anterior ST-Elevation Myocardial Infarction. CJC Open. 2022 Nov 5;5(1):77-85. doi: 10.1016/j.cjc PMID 36700188
- Cioffi GM, Madanchi M, Bossard M, Cuculi F. Deferring stent optimization in stent thrombosis: A novel approach for STEMI management-Insights from a case series. Clin Case Rep. 2021 Feb 13;9(3):1150-1154. doi: 10.1002/ccr3.3697. eCollection 2021 Mar. PMID 33768799
Идентификаторы
NCT: NCT04988672 · 2020-02559