NCT07138638尚未招募不适用
High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction: A Prospective, Multicenter Cohort Study
The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 1,112 人开始时间: 2025年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,112
- 试验地点
- 1
- 主要终点
- To evaluate the predictive value of high-frequency QRS (HF-QRS) parameters for major adverse cardiovascular events (MACE) within 1 year after PCI in AMI patients and to construct a prognostic risk prediction model.
研究概览
简要总结
This observational study aimed to investigate the prognostic value of high-frequency QRS (HF-QRS) in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI), as well as its potential role in diagnosing microvascular dysfunction. The main question it aims to answer is:
- Whether HF-QRS could serve as an effective tool for early identification of high-risk AMI patients and prognosis prediction;
- Whether HF-QRS provides auxiliary diagnostic value for post-AMI microvascular dysfunction.
Participants underwent HF-QRS assessment and were prospectively followed for 1 year to record the incidence of major adverse cardiovascular events (MACE).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years (inclusive)
- •Diagnosed with acute myocardial infarction (AMI, including STEMI and NSTEMI) and underwent successful emergency PCI
- •Voluntarily participated and provided written informed consent
排除标准
- •History of prior myocardial infarction or chronic heart failure
- •QRS duration >120 ms (including paced rhythm, WPW syndrome, bundle branch block, or left ventricular hypertrophy with repolarization abnormalities)
- •Structural heart disease (congenital heart disease, cardiomyopathy, aortic dissection, etc.)
- •Persistent atrial fibrillation or malignant arrhythmias
- •History of cerebral hemorrhage or ischemic stroke within 1 month
- •Prolonged cardiopulmonary resuscitation or requiring advanced life support (IABP/ECMO, etc.)
- •Scheduled for imminent surgery with anticipated inability to complete HF-QRS assessment
- •Other life-threatening conditions including: Severe hepatic or renal dysfunction;Uncontrolled systemic diseases;Hematologic disorders;Active infections;Malignancy with life expectancy <1 year Other investigator-determined exclusionary conditions:Pregnancy;Concurrent participation in other clinical trials
- •Refusal to participate in the clinical study
结局指标
主要结局
To evaluate the predictive value of high-frequency QRS (HF-QRS) parameters for major adverse cardiovascular events (MACE) within 1 year after PCI in AMI patients and to construct a prognostic risk prediction model.
时间窗: 12 months
次要结局
- To evaluate the adjunctive diagnostic value of high-frequency QRS parameters for microvascular dysfunction in ACS patients following percutaneous coronary intervention(12 months)
研究者
研究点 (1)
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