跳至主要内容
临床试验/NCT06215248
NCT06215248招募中不适用

Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease

Tartu University Hospital1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年2月1日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaak Kals

Professor of Vasology

Tartu University Hospital

研究点 (1)

Loading locations...

相似试验

Myocardial Dysfunction Evaluation in Lower Extremity... | 临床试验