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临床试验/NCT03364387
NCT03364387已完成不适用

The Clinical Profile, Management and Long-Term Outcomes of Patients With Acute Coronary Syndrome and Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

Cardiovascular Academy Society, Turkey1 个研究点 分布在 1 个国家目标入组 16,026 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16,026
试验地点
1
主要终点
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death

研究概览

简要总结

The objective of this study is to analyze the Demographics, Clinical Profiles, Management, in-Hospital and Long-Term Outcomes of Patients with Acute Coronary Syndrome Syndrome And Myocardial Infarction with Non-obstructive Coronary Artery Disease.

详细描述

Acute coronary syndrome is leading causes of death worldwide. Although, >90% of these patients had of culprit coronary lesion, a significant proportion of them had no any angiographic evidence of obstructive coronary arteries. Exact mechanism of the myocardial infarction remains unclear of these patients. However, MI registries have reported that the 5% to %10 of MI patients have no evidence of obstructive coronary artery disease.

There is lack of any data regarding prevalence, demographics, patients' profile, management, and outcome of this clinical entity in Turkish population. This registry aims to obtain these data in Myocardial Infarction with Non-obstructive Coronary Artery Disease patients in Turkish population.

Although there are huge data in this issue from different country and geographic areas, to date no any national data about prevalence, demographics, management and in-hospital outcomes of AF patients who admitting with cute coronary syndrome. With this rationale the registry also aims to obtain demographics, clinical profile, management, and in-hospital outcome of AF in Turkish Acute coronary syndrome population.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years
  • Evidence of an MI as defined any one of the following criteria:
  • Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
  • i. Symptoms of ischaemia. ii. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
  • iii. Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
  • v. Identification of an intracoronary thrombus by angiography.
  • Invasive diagnostic coronary angiography (IDCA) findings to allow determination of the presence /absence of obstructive coronary artery disease
  • Signed informed consent form to trial participation

排除标准

  • Inability/Refused to provide informed consent
  • Age below 18 years
  • Patients with unstable angina pectoris (ACS without increase and/or decrease of a cardiac biomarker, preferably high-sensitivity cardiac troponin, with at least one value above the 99th percentile of the upper reference limit)
  • Patients refused invasive diagnostic coronary angiography
  • Myocardial infarction associated with revascularization procedures

结局指标

主要结局

Composites of Myocardial Infarction, Hospitalization, Revascularization, Death

时间窗: 12 months

Re-infarction, Any cause or Cardiovascular Hospitalization or Death

次要结局

  • Atrial Fibrillation(12 months)
  • Heart failure(12 months)

研究者

发起方
Cardiovascular Academy Society, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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