NCT06215248招募中不适用
Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- left ventricular global longitudinal strain (GLS)
研究概览
简要总结
Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.
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
- 未提供
排除标准
- •Age <35 or >85 years
- •BMI ≥40 kg/m²
- •Known heart failure in history
- •Any acute or chronic autoimmune or rheumatic disease
- •Cardiac structural disease in history: inflammatory, infiltrative diseases, nonischemic cardiomyopathies
- •Acute coronary syndrome in last 3 months
- •Moderate to severe cardiac valvular disease
- •Cardiac valvular disease operative/invasive treatment in history
- •Cardiac implantable electronic device (CIED)
- •Transitory ischemic attack or stroke in last 3 months
- •Severe COPD (GOLD C or D)
- •Moderate to severe asthma (according to GINA 2022 criteria)
- •Untreated hypertension (noninvasive blood pressure measurement ≥180/110 mmHg during recruitment)
- •Chronic severe kidney dysfunction (eGFR <30 ml/min/1,73 m²)
- •Malignant tumor with radiation treatment to thorax, oncologic or biologic treatment in history
- •Chronic hematologic disease (except for anemia)
- •Severe liver dysfunction
- •Malignant tumor with <5 years of remission
- •Acute or chronic infectious disease
- •Anemia with hemoglobin <80 g/L
结局指标
主要结局
left ventricular global longitudinal strain (GLS)
时间窗: after enrollment and one year later
assessed by deformation analysis with echocardiography
次要结局
- other echocardiographic parameters(after enrollment and one year later)
- heart failure diagnosis(after enrollment and if necessary, reassessment one year later)
- cardiac- and renal injury markers(after enrollment and one year later)
- arterial stiffness(after enrollment and one year later)
- metabolomics(after enrollment and one year later)
- markers of oxidative stress(after enrollment and one year later)
研究者
Jaak Kals
Professor of Vasology
Tartu University Hospital
研究点 (1)
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