跳至主要内容
临床试验/NCT05098977
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

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

发起方
Grigore T. Popa University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Adrian Covic

Professor coordinator

Grigore T. Popa University of Medicine and Pharmacy

研究点 (1)

Loading locations...

相似试验