Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction

Обзор

At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.

Подробное описание

A total of 2146 patients with AMI are expected included as the research objects and randomly divided into experimental group and control group with 1073 cases in each group. After admission, Patients in the experimental group received everyday RIPC of upper limbs to the end of follow-up.The control group is a blank control and undergoes conventional medical procedures. Routine blood indexes, ultrasound, electrocardiogram, were detected On the day of admission. 12 months post- discharge, the incidence of MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, stent thrombosis, revascularization, stroke, admission due to heart failure and the above composite events were independent components) and Poce(All deaths, all strokes, all myocardial infarction, or all revascularization events)will recorded by telephone follow-up.

Вмешательства

• Другое RIPerC
  Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles
• Другое RIPC
  Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles

Первичные конечные точки

• Rate of MACCEs [Срок оценки: 12 months after discharge]

Вторичные конечные точки (6)

• Rate of Cardiovascular death events [Срок оценки: 12 months after discharge]
• Rate of non-fatal acute myocardial infarction events [Срок оценки: 12 months after discharge]
• Rate of revascularization events [Срок оценки: 12 months after discharge]
• Rate of stroke events [Срок оценки: 12 months after discharge]
• Rate of admission due to heart failure events [Срок оценки: 12 months after discharge]
• Rate of all all-cause death events [Срок оценки: 12 months after discharge]

Критерии участия

Критерии включения

• Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"

Критерии исключения

• The patients could not tolerate RIPC or RIPerC
• Aortic dissection, coronary artery aneurysm, coronary artery fistula and other systemic organic diseases
• The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively
• severe liver dysfunction (bilirubin > 20 mmol / L, prothrombin time > 2.0 ratio)
• Severe renal insufficiency (GFR < 30 ml / min / 1.73 m2);
• patients taking nicorandil and other drugs affecting microcirculation
• pregnant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Central China Cardiovascular Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT07181356 · HenanICE202105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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