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临床试验/NCT03515122
NCT03515122已完成不适用

The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment

Lund University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Assesses atherosclerosis in the coronary arteries

研究概览

简要总结

The main aim of this study is to gain an in-depth knowledge of cardiopulmonary and autonomic health consequences, and related risk factors among people with long-term high-level spinal cord injury. The result of this study will form the basis for further research to improve prevention strategies and risk prediction of cardiopulmonary disorders in people with spinal cord injury.

详细描述

Life expectancy for people with spinal cord injury (SCI) has increased during the 20th century as a result of improvements in health care systems and the environment. The incidence of SCI is stable and as a consequence the prevalence of SCI has increased globally leading to a growing population of persons aging with SCI. Therefore, SCI research need to focus on the physiology of aging to prevent premature cardiovascular and pulmonary diseases, which are the leading causes of death.

The disruption of sensory-, motor- and autonomic pathways causes major neurological deficits which alter the physiologic conditions. Among people with SCI above the mid-thoracic level dysfunction in pulmonary, autonomic cardiovascular regulation and emerging metabolic cardiovascular risk factors are well-known. In addition, paralysis of the abdominal and thoracic musculature causes restrictive pulmonary dysfunction, weak cough and atelectasis contributing to the mortality in SCI.

Cardiovascular disease (CVD) is more prevalent and occurs earlier in life among people with SCI compared to the general population. The increased prevalence of traditional risk factors cannot, however, fully explain these findings. Cardiovascular autonomic dysfunction has been hypothesized to contribute to the increased risk. The need for advances in risk management is therefore important as the first symptoms of coronary atherosclerosis are commonly sudden death or acute coronary syndrome. This is further complicated by the sensory loss and reduced ability to perform strenuous activities leading to asymptomatic disease as typical symptoms of exertional angina pectoris does not manifest. Risk assessment tools, such as Framingham risk score or Systematic Coronary Risk Evaluation (SCORE), are available but lack the precision in people with SCI as these tools are calibrated on the general population.

The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment - SPICA - was initiated to assess the effects of aging with SCI on the cardiovascular, pulmonary and autonomic systems in a cohort of middle-aged persons with long-term SCI. SPICA combines advanced imaging techniques, likely to play an important role in risk stratification of CVD and pulmonary disease in the future, with functional analyses, and generic and SCI-specific assessment tools.

The overarching aim of SPICA is to assess and extensively characterize the cardiopulmonary and autonomic health status in middle-aged persons with a severe and high-level SCI. The study will elucidate the cardiopulmonary health consequences specific to persons living with a SCI through comparison of results to matched controls. The results of SPICA will advance the investigator's knowledge in this field and thereby improve prevention strategies and risk prediction of CVD and pulmonary disorders in people with SCI.

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
50 Years 至 65 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

  • 未提供

结局指标

主要结局

Assesses atherosclerosis in the coronary arteries

时间窗: Day 1

Coronary CT Angiography

Intima media thickness in the carotid arteries

时间窗: Day 1

Ultrasound of carotid arteries to measure intima media thickness

Prevalence of structural changes in the lung tissue

时间窗: Day 1

High resolution CT scan

Orthostatic blood pressure

时间窗: Day 1

Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.

Plaques in the carotid arteries

时间窗: Day 1

Ultrasound of carotid arteries to measure and characterize plaques.

Coronary artery calcium score

时间窗: Day 1

Measures the amount of calcium in the coronary arteries from computed tomography imaging. Scores from 0 to \>1000, a higher value represents a worse outcome. Value \>0 indicates coronary atherosclerosis.

Ectopic fat distribution

时间窗: Day 1

CT body composition of epicardium, liver, abdomen and muscle

Heart rate response to deep breathing

时间窗: Day 1

Measures electrocardiography the activity of the autonomic nervous system based on the time and frequency domain indices of heart rate variability during deep breathing.

次要结局

  • Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)(Day 1)
  • Hospital Anxiety and Depression Scale (HADS)(Day 1)
  • Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI)(Day 1)
  • Glycated hemoglobin (HbA1c)(Day 1)
  • high sensitive C-reactive protein (hsCRP)(Day 1)
  • Hemoglobin(Day 1)
  • Trombocytes(Day 1)
  • Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)(Day 1)
  • Lymphocytes(Day 1)
  • Monocytes(Day 1)
  • Body weight(Day 1)
  • Hip circumference(Day 1)
  • Sense of Coherence Scale (SOC-13)(Day 1)
  • American Spinal Injury Association (ASIA) Impairment Scale(Day 1)
  • Total cholesterol(Day 1)
  • Spinal Cord Independence Measure (SCIM III)(Day 1)
  • Modified Ashworth Scale(Day 1)
  • High density lipoproteins (HDL)(Day 1)
  • Cystatin C(Day 1)
  • Creatinine(Day 1)
  • Erythrocytes(Day 1)
  • Leukocytes(Day 1)
  • Absolute glomerular filtration rate (GFR)(Day 1)
  • Accelerometry(Seven days)
  • 24-hour Holter-ECG(Day 1)
  • Spirometry(Day 1)
  • Questionnaire(Day 1)
  • Low density lipoproteins (LDL)(Day 1)
  • Fasting plasma glucose(Day 1)
  • Erythrocyte volume fraction (EVF)(Day 1)
  • Erythrocytes Mean Corpuscular Volume (Erc-MCV)(Day 1)
  • Body height(Day 1)
  • Electrocardiography(Day 1)
  • Impulse oscillometry(Day 1)
  • Triglycerides(Day 1)
  • Urate(Day 1)
  • Waist circumference(Day 1)
  • Neutrophils(Day 1)
  • Basophils(Day 1)
  • Resting blood pressure(Day 1)
  • Eosinophils(Day 1)
  • Advanced glycation endproduct (AGE)(Day 1)
  • Arterial stiffness(Day 1)
  • Body mass index(Day 1)
  • Ankle-brachial index(Day 1)
  • Ambulatory 24-hour blood pressure(Day 1)
  • Gas diffusing capacity (DLCO)(Day 1)

研究者

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

Jan Lexell

Professor, Senior Consultant

Lund University

研究点 (1)

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