NCT05098977尚未招募不适用
The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction: From Primary Angioplasty to Secondary Long-term Prevention - a Single Centre, Prospective, Observational Cohort Study
Grigore T. Popa University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality and major adverse cardiovascular events (MACE)
研究概览
简要总结
Aims
- heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI);
- measurement of HRV using a device approved for medical use in Europe;
- assessment of the correlation between HRV and short- and long-term adverse cardiovascular events (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease) in patients treated by primary PCI for acute myocardial infarction;
- creating a registry of HRV parameters measured in a contemporary cohort of patients with acute myocardial infarction.
详细描述
The following data will be collected:
- general demographic data;
- time from chest pain onset to primary PCI;
- comorbidities (ischemic heart disease, arterial hypertension, previous PCI or coronary artery bypass surgery - CABG, heart failure, peripheral artery disease, atrial fibrillation, stroke, diabetes mellitus, kidney disease);
- cardiovascular risk factors (age, body mass index, smoking, abdominal perimeter, sedentarism, gender, inflammation);
- cardiac rhythm derived from electrocardiographic data;
- HRV time- and frequency domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio);
- routine biological data and biomarkers, including creatine kinase-MB (CK-MB), aspartate transaminase (AST), lactate dehydrogenase (LDH) and cardiac-specific troponin;
- left ventricular ejection fraction at admission, at discharge and at follow-up (1 month, 6 months and 1 year);
- initial and final thrombolysis in myocardial infarction (TIMI) flow;
- type of stent used for coronary angioplasty;
- Global Registry of Acute Coronary Events (GRACE) score;
- SYNTAX score II in case of three-vessel coronary disease or involving left main stem;
- in-hospital, one month and long-term clinical outcomes (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease).
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ST-Elevation Myocardial Infarction (STEMI) treated with primary PCI within 12 hours from symptoms onset;
- •patients in sinus rhythm;
- •patients who have read and signed the standard informed consent regarding enrolment in the study.
排除标准
- •unconscious or intubated patients who are unable to sign the standard informed consent;
- •patients with atrial fibrillation;
- •patients with sinus node dysfunction or atrioventricular block of any degree;
- •frequent premature supraventricular or ventricular contractions;
- •paced ventricular rhythm;
- •patients treated with positive inotropic and chronotropic drugs;
- •history of myocardial infarction or myocardial revascularization (PCI or CABG);
- •patients refusal.
结局指标
主要结局
Composite of all-cause mortality and major adverse cardiovascular events (MACE)
时间窗: in-hospital, 1 month and 1 year
MACE will be defined as cardiac mortality, fatal and non-fatal myocardial infarction, unplanned target vessel revascularization and stroke)
次要结局
- Target vessel revascularization(in-hospital, 1 month and 1 year)
- Stroke(in-hospital, 1 month and 1 year)
- Cardiac mortality(in-hospital, 1 month and 1 year)
- Fatal and non-fatal myocardial infarction(in-hospital, 1 month and 1 year)
- All-cause mortality(in-hospital, 1 month and 1 year)
- Target lesion revascularization(in-hospital, 1 month and 1 year)
研究者
Professor Adrian Covic
Professor coordinator
Grigore T. Popa University of Medicine and Pharmacy
研究点 (1)
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