Clinical Outcomes of Patients With Coronary Artery Disease

Официальное название

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Обзор

Coronary heart disease (CHD) stands as a foremost contributor to global mortality, characterized by complex pathogenesis that renders conventional "one-size-fits-all" preventive strategies inefficient. Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Подробное описание

Coronary heart disease (CHD) stands as a foremost contributor to global mortality. Despite the increasing investment in the prevention of risk factors and the popularization of percutaneous coronary intervention (PCI), the age-standardized incidence and mortality of CHD continue to increase. CHD is characterized by complex pathogenesis, rendering conventional "one-size-fits-all" preventive strategies inefficient.

Currently, there is a need to address two critical challenges. The first centers on early detection, precise risk stratification, and personalized intervention strategies for high-risk CHD patients, with a focus on the exploration of inflammation-driven risks, lesion-based risk stratification, and tailored anti-thrombotic therapies. The second challenge lies in the transformation of clinical risk assessment and decision-making processes into a precise level through the utilization of big data mining techniques.

Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Первичные конечные точки

• Ischemic events [Срок оценки: During 12-month follow up]

Вторичные конечные точки (5)

• Major adverse cardiovascular and cerebrovascular events (MACCE) [Срок оценки: During 1/2/3/4/5-year follow up]
• Cardiac death [Срок оценки: During 1/2/3/4/5-year follow up]
• Stent thrombosis [Срок оценки: During 1/2/3/4/5-year follow up]
• Major bleeding events [Срок оценки: During 1/2/3/4/5-year follow up]
• Clinical relevant bleeding events [Срок оценки: During 1/2/3/4/5-year follow up]

Критерии участия

Критерии включения

• Age ≥ 18 years old
• Hospitalization due to either confirmed or suspected CHD combined with one of the following features: previous PCI or CABG; previous myocardial infarction; previous coronary angiography revealing ≥ 50% stenosis in major coronary vessels; presentation with chest pain and pre-test probability of CHD > 65%; laboratory tests revealing objective evidence of myocardial ischemia; coronary CT angiography (CTA) showed ≥ 30% stenosis in major coronary vessels
• Subjects undergoing at least one coronary imaging and one functional examination. Imaging examinations include coronary CTA, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Functional examination include fraction flow reservation (FFR), CT-FFR or quantitative flow ratio (QFR).
• Written informed consent provided.

Критерии исключения

• History of mental illness, drug or alcohol abuse, or being unable to cooperate with follow-up visits for any reason;
• Life expectancy <1 year
• Pregnant or plan to be pregnant within 1 year
• Subjects participating in any other clinical trial
• Other conditions deemed unsuitable for inclusion by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• General Hospital of Northern Theater Command — Шэньян

Публикации

• Liu S, Li Y, Zeng X, Wang H, Yin P, Wang L, Liu Y, Liu J, Qi J, Ran S, Yang S, Zhou M. Burden of Cardiovascular Diseases in China, 1990-2016: Findings From the 2016 Global Burden of Disease Study. JAMA Cardiol. 2019 Apr 1;4(4):342-352. doi: 10.1001/jamacardio.2019.0295. PMID 30865215
• writing committee of the report on cardiovascular health and diseases in china. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary. Biomed Environ Sci. 2022 Jul 20;35(7):573-603. doi: 10.3967/bes2022.079. PMID 35945174
• Currie G, Delles C. Precision Medicine and Personalized Medicine in Cardiovascular Disease. Adv Exp Med Biol. 2018;1065:589-605. doi: 10.1007/978-3-319-77932-4_36. PMID 30051409
• Liberale L, Badimon L, Montecucco F, Luscher TF, Libby P, Camici GG. Inflammation, Aging, and Cardiovascular Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Mar 1;79(8):837-847. doi: 10.1016/j.jacc.2021.12.017. PMID 35210039
• Marnell CS, Bick A, Natarajan P. Clonal hematopoiesis of indeterminate potential (CHIP): Linking somatic mutations, hematopoiesis, chronic inflammation and cardiovascular disease. J Mol Cell Cardiol. 2021 Dec;161:98-105. doi: 10.1016/j.yjmcc.2021.07.004. Epub 2021 Jul 21. PMID 34298011
• Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic D PMID 28845751
• Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. d PMID 31733140
• Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colc PMID 32865380

Идентификаторы

NCT: NCT06216847 · COCAD V1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗