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临床试验/NCT02388139
NCT02388139Unknown不适用

Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (AMI) Included in the Romanian National Programme of Primary Percutaneous Revascularisation - a Single Center Observational 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: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
renal artery stenosis incidence

研究概览

简要总结

Aims

  • assessment of renal artery stenosis incidence in consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;
  • generating a cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
  • creating a local registry (based on European CARDS percutaneous interventional registries) which also includes renal, metabolic and vascular data;
  • reporting long-term follow-up data on major cardiac adverse events (MACE) in the study group.

详细描述

Gathered data:

  • descriptive general demographic data;
  • previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease), cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
  • routine biological data and specific non-genetic biomarkers;
  • information regarding primary PCI (less than 12 hours of ischemic symptoms): coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
  • echocardiography at admission (LVEF);
  • metabolic data (obtained from body composition monitoring) - body water, body fat tissue;
  • renal arteries angiographic details (two independent operators evaluate stenosis based on a predefined scale);
  • renal dimensions;
  • measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
  • heart rate variability;
  • in-hospital and one month follow-up 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults with AMI (<12h) diagnostic confirmed;
  • included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

排除标准

  • 未提供

结局指标

主要结局

renal artery stenosis incidence

时间窗: 2 years

assessment of in renal artery stenosis incidence consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;

次要结局

  • cardio-renal-metabolic profile in patients with renal atherosclerotic disease;(2 years)

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)

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