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
- 否
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
Professor Adrian Covic
Professor coordinator
Grigore T. Popa University of Medicine and Pharmacy
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac CatheterizationRenal Artery StenosisNCT00885768Imam Khomeini Hospital146
已完成
不适用
Serum Uremic Toxins and Histological Findings of the Blood Vessels in Dialysis PatientsChronic Renal FailureNCT00412139University of Skopje100
终止
不适用
Renal Function in Patients Submitted to Myocardial Revascularization SurgeryCoronary DiseaseNCT00905775UPECLIN HC FM Botucatu Unesp60
Unknown
2 期
Renal Stenting With Distal Atheroembolic ProtectionRenal Artery ObstructionRenovascular HypertensionNCT00868972Universita di Verona150
已完成
3 期
Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic LesionsCardiovascular DiseasesHypertension, RenovascularRenal Artery ObstructionAtherosclerosisNCT00081731Baim Institute for Clinical Research947
