The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence (%) of Death during follow up
研究概览
简要总结
Myocardial infarction with non-obstructive coronary arteries (MINOCA) occurs in 1-13% of all patients with acute myocardial infarction (AMI). According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones, but face a significant risk for recurrent events of angina. It has been demonstrated that sympathetic nervous system (SNS) overdrive during the acute phase of an acute coronary syndrome (ACS) has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms. In the setting of MINOCA, however, data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach.
The aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients. In the same context, this study is the first, to the investigators' knowledge, registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance (CMR) imaging.
This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 38-85 years old who fulfill the diagnostic criteria of MINOCA. Patients will receive treatment according to the latest guidelines and consensus documents. Assessment of SNS will include calculation of indices of heart rate and blood pressure variability, as well as the measurement of muscle sympathetic nerve activity (MSNA) during the first 14 days following the event. Follow-up will include a phone contact at 3, 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints. Definition of primary endpoints includes hospitalization for new onset of ACS, heart failure, stroke or transient ischemic attack, cardiovascular death or death from any cause. Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording, recurrent angina assessed via Seattle Angina Questionnaire (SAQ) and the general health condition and quality of life (QoL) assessed using SF-12 questionnaire.
The results of this study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms.
详细描述
BACKGROUND
Myocardial infarction with non-obstructive coronary arteries (MINOCA) occurs in 1-13% of all patients with acute myocardial infarction (AMI). According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones, but face a significant risk for recurrent events of angina. MINOCA consists a clinical entity characterized by a heterogeneous and poorly understood pathophysiological substrate (plaque disruption, coronary epicardial and microvascular spasm, thromboembolism, thrombophilia, spontaneous dissection, myocardial bridges, microvascular dysfunction), whereas current data leave significant knowledge gaps regarding the risk stratification and the proper therapeutical approach of these patients. Sympathetic nervous system (SNS) overdrive during the acute phase of an acute coronary syndrome (ACS) is an expected reflex mechanism aiming to maintain homeostasis. On the other hand, it has been demonstrated that it has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms. In the setting of MINOCA, however, data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach.
AIM OF THE STUDY
The primary aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients. Furthermore, investigators will assess relations between various SNS parameters and clinical characteristics of these patients, as well as other indices of cardiovascular function (biomarkers, imaging). In the same context, this study is the first, to the investigators' knowledge, registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance (CMR) imaging.
METHODS
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 35-85 years old.
- •Signed ICF.
- •Cases fulfilling the MINOCA criteria according to working group position paper and after CMR confirmation of ischemic pattern LGE (excluding myocarditis and Takotsubo)
排除标准
- •Age <35 and >85 years old
- •Myocarditis or Takotsubo (CMR confirmation)
- •No CMR available (CKD stage IV-V, pacemaker)
- •Inability to assess SNS (polyneuropathy, peripheral neuropathy, dysautonomy, permanent AF)
- •Severe valvular disease
- •LVEF<35%
- •Life expenctancy less than the follow up period on recruitement
- •Active cancer on treatment
- •Psychiatric illness compromising follow up
结局指标
主要结局
Incidence (%) of Death during follow up
时间窗: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Number of participants dead due to cardiovascular or any other cause
Incidence (%) of Hospitalization for Major Cardiovascular Events (MACEs) during follow up
时间窗: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Number of participants hospitalized due to: ACS (STEMI,NSTEMI,Unstable Angina), Decompensated heart failure, Stroke
Incidence (%) of the Composite endpoint
时间窗: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Incidence (%) of the composite endpoint that includes: Number of participants either hospitalized for MaCEs (ACS, Decompensated heart failure, Stroke) or dead due to a cardiovascular or any other cause
次要结局
- Frequency (%) of increased long term arrythmia burden(Assessed at 18 months after the acute event)
- Assessment of Sentimental status(Assessed at 1-14 days and 18 months after the acute event)
- Frequency of long term Sustained/ Reccurent Angina(Assessed at 18 months after the acute event)
- Assessment of Quality of Life and General Health Status(Assessed at 1-14 days and 18 months after the acute event)
研究者
Konstantinos Tsioufis
Konstantinos Tsioufis, Prof. of Cardiology
Hippocration General Hospital