Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Left ventricular end-diastolic volume (ml)
研究概览
简要总结
This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI/D (above Th6) who have AD and 24 individuals with low-level SCI/D (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling.
All 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI/D population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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 aged 18 years or older
- •long-term (>10 years), motor-complete SCI/D (AIS A and B)
- •Group A (24 individuals): high-level (>Th6) SCI/D and autonomic dysreflexia
- •Group B (24 individuals): low-level (<Th10) SCI/D without autonomic dysreflexia
- •signed informed consent
排除标准
- •congenital heart defects
- •valvular disease(s)
- •cardiomyopathy
- •medium to severe arrhythmia
- •myocardial infarction
- •comorbidities causing morphologic heart changes including primary hypertension, aortic stenosis
- •comorbidities causing arterial hypertension
- •use of anti-hypertensive treatment
- •individuals after sacral deafferentation surgery
- •pregnancy
- •active implanted medical devices
- •claustrophobia
- •inability to comply with the measurement procedures
研究组 & 干预措施
AD+
Spinal Cord Injury, above Th6, AIS A or B, Autonomic Dysreflexia
AD-
Spinal Cord Injury, below Th10, AIS A or B, no Autonomic Dysreflexia
结局指标
主要结局
Left ventricular end-diastolic volume (ml)
时间窗: baseline
Left ventricular end-diastolic volume assessed by cardiac MRI
次要结局
- Left ventricular mass (g)(baseline)
- Left ventricular end systolic volume (ml)(baseline)
- Left ventricular ejection fraction (%)(baseline)
- B-type natriuretic peptide level (pg/ml)(baseline)