The Effect of Autonomic Neuropathy Status on the Endpoint Events in Diabetes Patients With Coronary Heart Disease and Sleep Apnea: a Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 326
- 主要终点
- All-cause death event
研究概览
简要总结
Background: diabetes combined with cardiac autonomic neuropathy (CAN) can denervate the heart, which may prevent patients with sleep apnea syndrome from bradycardia in the early stage, and directly show an increased risk of tachyarrhythmia and sudden cardiac death. This means that many diabetes patients with sleep apnea syndrome who are at risk of sudden death may be ignored due to the lack of the typical signal of "bradycardia". A study showed 299 events among 165 participants, of which 132 participants (10%) had CAN and experienced 244 cardiovascular events, and 33 participants (25%) had CAN and experienced 55 cardiovascular events (hazard ratio [HR] 2.79, 95% CI 1.91). In this trial, the effect of autonomic neuropathy on the end point events of type 2 diabetes patients with coronary heart disease and sleep apnea was investigated.
Objective: This study is a prospective, single-center, observational study to investigate the effect of autonomic neuropathy status on the endpoint events in patients with coronary heart disease, diabetes, and sleep apnea syndrome.
Methods : Diagnosed coronary heart disease (coronary angiography showed coronary artery stenosis ≥ 50%), diabetes (fasting blood glucose ≥ 7 mmol/L, blood glucose ≥ 11.1 mmol/L 2 hours after OGTT meal, HbA1c ≥ 6.5%, or random blood glucose ≥ 11.1 mmol/L), sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep (AHI ≥ 5 times/hour), and associated symptoms or health risks. ）The patient. The Ewing test was divided into two groups: the group without concomitant cardiac autonomic neuropathy and the group with cardiac autonomic neuropathy. The primary endpoint includes all-cause mortality events during follow-up, and the secondary endpoint includes the occurrence of cardiovascular events.
This study will explore the influence of autonomic neuropathy on the endpoint events of patients with diabetes, coronary heart disease and sleep apnea.
Keywords: coronary heart disease, diabetes, sleep apnea syndrome, cardiovascular autonomic neuropathy, results
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was diagnosed with coronary heart disease (coronary angiogram showed coronary artery stenosis ≥ 50%), diabetes (fasting blood glucose ≥ 7 mmol/L, blood glucose ≥ 11.1 mmol/L 2 hours after OGTT meal, HbA1c ≥ 6.5%, or random blood glucose ≥ 11.1 mmol/L), and sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep, that is, AHI ≥ 5 times/hour, with associated symptoms or health risks. ）.
排除标准
- •Patients who have been implanted with permanent pacemakers; Patients with severe arrhythmia or myocardial infarction/stroke in the past 3 months; 48 hours prior to the experiment, the use of beta blockers, beta agonists ACE-I、ARB、 Patients with drugs such as adrenaline and dopamine; Pregnant women; Patients with serious diseases of important organs (such as heart, brain, kidney, liver, etc.); Patients with mental or physical disabilities; Unable to cooperate with patients undergoing examinations; Suspected or diagnosed patients with a history of alcohol or drug abuse; Patients with acute complications of diabetes, such as DKA, hypertonic coma, lactic acidosis, etc; Patients with thyroid dysfunction; Patients at risk of cardiac autonomic neuropathy (CAN), such as those with severe hypertension or proliferative retinopathy; Patients with electrolyte disorders such as hypokalemia.
研究组 & 干预措施
CAN group
Cardiovascular autonomic neuropathy group
干预措施: The total score of Ewing test (i.e. cardiovascular autonomic reflex test and heart rate variability) was ≥1, which was divided into cardiac autonomic neuropathy group (CAN grou (Behavioral)
Non-CAN group
Non-Cardiovascular autonomic neuropathy group
结局指标
主要结局
All-cause death event
时间窗: Follow up endpoint events after 3 years of enrollment.
次要结局
- cardiovascular events(Follow up endpoint events after 3 years of enrollment.)
研究者
Jianping Zeng
Dean, Xiangtan Central Hospital ,Director of cardiovascular clinic, Clinical Professor
Xiangtan Central Hospital