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临床试验/NCT06385834
NCT06385834招募中不适用

The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2024年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
201
试验地点
1
主要终点
left ventricle ejection fraction

研究概览

简要总结

The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients

详细描述

Cardiovascular disease (CVD) remains the first cause of mortality worldwide. More than 30% of CVD-connected fatalities are ascribed to ST-segment Elevation myocardial infarction (STEMI). There is strong and consistent evidence that aerobic exercise after a STEMI improves overall and cardiovascular-related mortality. Aerobic exercise (AE) acts in key mechanisms of cardiac remodeling and function improvement after STEMI, thus contributing both to prevent or postpone harmful adaptations, and even to recover from negative alterations caused by cardiac ischemia. However, the time of day to exercise for STEMI patients' optimal cardiac benefits is currently unknown.

The circadian clock endows the host with temporal precision and robust adaptation to the surrounding environment. Almost all physiologic, metabolic and endocrine processes, including glycolysis, lipid and carbohydrate metabolism as well as cardiovascular function (heart rate, blood pressure) are influenced by the circadian clock. Recent investigations in rodents utilizing gain-of-function/loss-of-function models and in humans have identified Adverse cardiovascular events have day/night patterns is related to endogenous circadian clock control of platelet activation events. Several studies have also demonstrated the effect of AE at different times on blood pressure. Indeed, timing is critical in amplifying the beneficial impact of AE. However, these studies did not address cardiac structural remodeling or other CVD-related metabolic markers, it difficult to determine the physiological and structural effects of different time AE on cardiovascular health.

Thus, In this trial our aim is to assess, in patients who have had an STEMI, AE in which time of a day can give the best benefits to cardiac remodeling and function improvement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work.

入排标准

年龄范围
17 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 75-years-old;
  • Typical symptoms of acute myocardial infarction within 24 hours, with ST segment elevation of ≥1mm in two consecutive leads on electrocardiogram
  • After receiving complete revascularization treatment
  • Cardiac function grading I to II without any other serious complications
  • Left ventricular ejection fraction >30%
  • Compliant with the guidelines of the American College of Cardiology/American Heart Association for participating in cardiac rehabilitation standards
  • Signed written informed consent.

排除标准

  • Patients with unstable angina
  • severe symptomatic congestive heart failure detectable myocardial ischemia
  • valvular disease requiring surgery
  • severe ventricular arrhythmias
  • severe concomitant life-threatening diseases such as cancer, and rheumatoid disease
  • osteoarticular diseases that may affect the exercise process

结局指标

主要结局

left ventricle ejection fraction

时间窗: at baseline,at the sixth week, and after the 12th week of training or follow-up

Use cardiac ultrasound system to measure left ventricle ejection fraction

次要结局

  • Endothelial Function(at baseline,at the sixth week, and after the 12th week of training or follow-up)
  • Skeletal muscle and fat mass(at baseline,at the sixth week, and after the 12th week of training or follow-up)
  • Oxygen consumption(at baseline,at the sixth week, and after the 12th week of training or follow-up)
  • Cardiac structure(at baseline,at the sixth week, and after the 12th week of training or follow-up)
  • glucose(at baseline, at the sixth week, and after the 12th week of training or follow-up)
  • One year major Adverse Cardiovascular Events(From baseline to one year after participating in rehabilitation)
  • VE/VCO2-SLOPE(at baseline,at the sixth week, and after the 12th week of training or follow-up)
  • Flow-mediated dilation(at baseline, at the sixth week, and after the 12th week of training or follow-up)
  • N-terminal pro-BNP(at baseline, at the sixth week, and after the 12th week of training or follow-up)
  • Blood lipid(at baseline, at the sixth week, and after the 12th week of training or follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Pu

professor

RenJi Hospital

研究点 (1)

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