Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Number of major adverse cardiovascular events, major adverse limb events and deaths
研究概览
简要总结
Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.
Current study aims to identify novel prognostic biomarkers for better risk stratification of late stage LEAD patients. It also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- •Fontaine stage I-IIa;
- •acute limb ischemia;
- •age <35 or >85 years;
- •fasting < 6 hours;
- •time since the last use of tobacco products < 4 hours;
- •body mass index ≥ 40 kg/m2
- •blood pressure ≥ 180/120mmHg;
- •unstable angina;
- •atrial fibrillation at the time of presentation;
- •myocardial infarction, stroke or TIA during the preceding 3 months;
- •any revascularization during the preceding 1 month;
- •severe heart failure (NYHA IV);
- •clinically significant heart valve disease;
- •severe physical disability (other than limb ischemia);
- •acute infectious disease;
- •active malignancy or chemotherapy or disease-free < 5 years;
- •type 1 diabetes;
- •uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine disorders;
- •moderate to severe asthma (GINA 2016);
- •severe chronic obstructive pulmonary disease (mMRC grade 3-4)
- •acute (KDIGO 2012) or chronic renal disease (eGFR-EPI <30mL/min/1.73 m2);
- •clinically significant acute or chronic liver disease;
- •severe anemia (<80 g/L);
- •clinically significant neuroinflammatory or neurodegenerative disease;
- •active rheumatism;
- •clinically significant connective tissue disease;
- •alcoholism or drug abuse;
- •psychotic disorders
结局指标
主要结局
Number of major adverse cardiovascular events, major adverse limb events and deaths
时间窗: 5 years
A composite of any of the following events, as documented by patients' hospital or death records: 1. nonfatal myocardial infarction or stroke 2. fatal myocardial infarction or stroke 3. hospitalization for angioplasty or bypass surgery for coronary or peripheral vessel disease 4. LEAD-related major lower extremity amputation 5. other cardiovascular deaths (cardiac arrest, lethal arrhythmia, heart failure, aortic dissection or rupture) 6. non-cardiovascular deaths
次要结局
- Number of fatal cardiovascular events(5 years)
- Number of non-fatal cardiovascular events(5 years)
- Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease(5 years)
- Number of LEAD-related major lower extremity amputations(5 years)
- Number of deaths from all causes(5 years)
研究者
Jaak Kals
Principal Investigator
University of Tartu