Меню
Идёт набор NCT07270887

The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks

— Наблюдательное ASCVD

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: remote ischemic conditioning.
Кому может быть актуально
Состояния в реестре: ASCVD. Базовые параметры: от 40 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks (RICMO-ASCVD): a Prospective, Blinded Endpoint, Multi-center, Cohort Study

Обзор

Atherosclerotic cardiovascular disease (ASCVD) is a group of disorders sharing atherosclerosis as a common pathological basis, primarily affecting the heart, brain, kidneys, and other peripheral arteries, leading to clinical syndromes characterized mainly by arterial ischemia. It has become the group of diseases with the highest morbidity and mortality rates worldwide. Patients with very high-risk ASCVD face an even greater risk of recurrence. Previous studies have discovered that remote ischemic conditioning (RIC) has protective effects on major organs such as the heart, brain, and kidneys. Given the cardiorenal and cerebrovascular protective effects of RIC, the invesitgators believe that long-term remote ischemic conditioning is a promising approach to preventing the recurrence of ASCVD events. Based on this hypothesis, the investigators have designed a prospective, multicenter cohort study with blinded outcome assessment to investigate the protective effects of long-term remote ischemic conditioning in very high-risk ASCVD populations.

Вмешательства

  • Устройство remote ischemic conditioning
    5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg

Первичные конечные точки

  • Incidence of Composite Endpoint Events [Срок оценки: 1 year]
Вторичные конечные точки (10)
  • Number of participants with no-fatal cardiovascular events [Срок оценки: 1 year]
  • Number of participants with no-fatal stroke [Срок оценки: 1 year]
  • Number of participants with no-fatal deterioration of renal function [Срок оценки: 1 year]
  • Change of renal function [Срок оценки: 1 year]
  • Change of blood pressure [Срок оценки: 1 year]
  • Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c) [Срок оценки: 1 year]
  • Number of participants with new onset diabetes [Срок оценки: 1 year]
  • Occurence of vascular death [Срок оценки: 1 year]
  • Barthel Index (BI) scores [Срок оценки: 1 year]
  • Death due to all causes [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age over 40 years
  • Two or more prior major ASCVD events; OR one documented major ASCVD event with two or more of the following risk factors
  • signed informed consent

Note： Definition of Major ASCVD Events:

A. Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).

C. Ischemic stroke or history of ischemic stroke. D. Symptomatic peripheral artery disease, defined as intermittent claudication with an ankle-brachial index (ABI) < 0.85, or prior limb revascularization or amputation.

Risk factors:

  • Age ≥65 y
  • Heterozygous familial hypercholesterolemia
  • History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major
  • ASCVD event(s)
  • Diabetes mellitus
  • Hypertension
  • CKD (eGFR 15-59 mL/min/1.73 m2)
  • Current smoking
  • Persistently elevated LDL-C (LDL-C ≥100 mg/dL \[≥2.6 mmol/L\]) despite maximally tolerated statin therapy and ezetimibe
  • History of congestive HF

Критерии исключения

  • Presence of severe neurological deficit (mRS score ≥ 3)
  • Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medication)
  • Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
  • Severe hematological disorders or significant coagulation abnormalities
  • Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
  • Severe comorbid conditions with a life expectancy of less than 1 year
  • Participation in another clinical trial within the past 3 months or ongoing participation
  • Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of Neurology, General Hospital of Northern Theater Command — Шэньян

Идентификаторы

NCT: NCT07270887 · Y (2025) 394

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗