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Набира участници Не е приложимо NCT05325034

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Не е приложима фаза (напр. обсервационно)
Заболявания: Cardiovascular Diseases Acute Coronary Syndrome Atherosclerosis Hypercholesterolemia

Спонсор: Stephen Nicholls

Налично на: БГ
Обобщение
Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.
Описание
The study will be conducted over two phases. In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period. In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up. Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice. * Patient-and-clinician 'Cholesterol score card'. This passport-sized document will serve as a communication, engagement and activation tool for patients. It will be provided to participants at the commencement of the intervention and filled out at each study follow up visit. Participants will be encouraged to fill out sections at clinically-driven follow up appointments with their treating clinicians (e.g. general practitioner, cardiologist). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies. * Risk stratification for recurrent events. As part of the intervention, each participant will have their SMART Risk score of a recurrent event assessed using the 'U-prevent' online calculator. In addition, each participant's Lp(a) will be measured and presented graphically on a continuum of risk. Both of these risk assessments will be sent to the treating primary care clinician and a copy provided to the participant. Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.
Кой може да участва
Inclusion Criteria: * 18 years of age * Admission for Type I myocardial infarction Exclusion Criteria: * LDL \<1.4mmol/L at baseline * Unable to provide contact details of primary care physician/general practitioner * Unable to provide written informed consent. * Unlikely to survive \>12 months
Места на провеждане 9
Австралия (1)
Illawarra Shoalhaven Local Health District
Wollongong , New South Wales
Китай (1)
Affiliated Zhongshan Hospital of Dalian University
Dalian , Liaoning
Индия (1)
All India Institute of Medical Sciences
New Delhi
Япония (1)
Fukuoka University Hospital
Fukuoka
NOT_YET_RECRUITING
Malaysia (1)
University Teknologi MARA, Hospital UiTM, UiTM Medical Centre
Shah Alam , Selangor
NOT_YET_RECRUITING
Сингапур (1)
National Heart Centre
Singapore
Южна Корея (1)
PyeongChon Hallym University Sacred Heart Hospital
Pyeongchon , Gyeonggi Province
NOT_YET_RECRUITING
Taiwan (1)
National Cheng Kung University Hospital
Tainan
Тайланд (1)
Siriraj Hospital
Bangkok
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.09.2022
Крайна дата
01.12.2026
Регистрационен номер
NCT05325034
Източник
anzctr
Запитване за медицински туризъм

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