Skip to content

The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment

The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03515122
Acronym
SPICA
Enrollment
125
Registered
2018-05-03
Start date
2017-11-15
Completion date
2018-06-30
Last updated
2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction, Cardiovascular Diseases, Pulmonary Disease, Spinal Cord Injuries

Keywords

Epidemiology, Rehabilitation, Clinical protocols, Middle aged

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Skane University Hospital
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Traumatic SCI * SCI duration \>5 years * Neurological level of lesion C1-T6 * ASIA Impairment Scale A-C * Resident in Skåne, Sweden * No dependency of full-time ventilation support Control group will consist of matched controls from the Swedish Cardiopulmonary and Bioimage Study's data of the general population.

Design outcomes

Primary

MeasureTime frameDescription
Coronary artery calcium scoreDay 1Measures 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.
Intima media thickness in the carotid arteriesDay 1Ultrasound of carotid arteries to measure intima media thickness
Assesses atherosclerosis in the coronary arteriesDay 1Coronary CT Angiography
Prevalence of structural changes in the lung tissueDay 1High resolution CT scan
Ectopic fat distributionDay 1CT body composition of epicardium, liver, abdomen and muscle
Heart rate response to deep breathingDay 1Measures electrocardiography the activity of the autonomic nervous system based on the time and frequency domain indices of heart rate variability during deep breathing.
Orthostatic blood pressureDay 1Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.
Plaques in the carotid arteriesDay 1Ultrasound of carotid arteries to measure and characterize plaques.

Secondary

MeasureTime frameDescription
Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)Day 1Self-reported spasticity scale that measures the impact of spasticity in activities of daily living. Ranges from -105 to 105. Low values represents a worse outcome
Sense of Coherence Scale (SOC-13)Day 1To assess the 3 dimensions of the SOC concept: comprehensibility (5 items), manageability (4 items), and meaningfulness (4 items). Value ranges from 13 to 91 and low values represent a worse outcome.
Hospital Anxiety and Depression Scale (HADS)Day 1Screening instrument for anxiety and depression. Consists of two subscales, one for depression and one for anxiety each ranging from 0-21, high value represents a worse outcome.
Spinal Cord Independence Measure (SCIM III)Day 1SCIM III comprises 19 areas of activities of daily living grouped into 3 subscales: self-care, respiratory and sphincter management, and mobility and measure self-reported activity limitation. SCIM III ranges from 0-100 and a low value represents a worse outcome.
Modified Ashworth ScaleDay 1Clinical examination of spasticity in specific muscles of the upper and lower extremities. The scale ranges from 0-4 with increasing scores indicating increased spasticity.
American Spinal Injury Association (ASIA) Impairment ScaleDay 1Measures the extent of spinal cord injury and the neurological level of injury. The extent of injury is classified as A-E. A (complete injury); B (sensory incomplete injury); C (motor incomplete injury, more than half of key muscle functions below the neurological level have a muscle grade 2 or less); D (motor incomplete injury, at least half of key muscle functions below the neurological level have a muscle grade 3 or more); E (normal sensory and motor function). i.e. from complete to normal neurological function. Thus A represents a worse outcome than E. The neurological level of injury reflects the most rostral spinal cord level with normal sensory and motor function.
Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI)Day 1Measures the occurrence and severity of autonomic dysreflexia (AD) and hypotension in spinal cord injury. Consists of two subscales ranging from 0-204 (AD) and 0-232 (hypotension) and a high value represents a worse outcome.
Total cholesterolDay 1Analysis of venous blood sample for total cholesterol levels
High density lipoproteins (HDL)Day 1Analysis of venous blood sample for total HDL-levels
Low density lipoproteins (LDL)Day 1Analysis of venous blood sample for LDL-levels
TriglyceridesDay 1Analysis of venous blood sample for triglycerides levels
Fasting plasma glucoseDay 1Analysis of venous blood sample for fasting plasma glucose level
Glycated hemoglobin (HbA1c)Day 1Analysis of venous blood sample for HbA1c level
high sensitive C-reactive protein (hsCRP)Day 1Analysis of venous blood sample for hsCRP level
Cystatin CDay 1Analysis of venous blood sample for Cystatin C level
Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)Day 1Analysis of venous blood sample for Erc-MCH level
Erythrocytes Mean Corpuscular Volume (Erc-MCV)Day 1Analysis of venous blood sample for Erc-MCV level
NeutrophilsDay 1Analysis of venous blood sample for neutrophils level
EosinophilsDay 1Analysis of venous blood sample for Eosinophils level
BasophilsDay 1Analysis of venous blood sample for Basophils level
LymphocytesDay 1Analysis of venous blood sample for lymphocytes level
MonocytesDay 1Analysis of venous blood sample for monocytes level
Absolute glomerular filtration rate (GFR)Day 1Calculated absolute GFR from Cystatin C level, body height, body weight, age and gender.
Body weightDay 1Recorded in kilograms with a portable scale for wheelchairs.
Body heightDay 1Recorded in centimeters in supine position using a flexible measure tape
HemoglobinDay 1Analysis of venous blood sample for Hemoglobin level
Hip circumferenceDay 1Recorded in centimeters in supine position using a flexible measure tape
Body mass indexDay 1Produced by dividing the body weight in kilograms with the body height in meters to the power of two
AccelerometrySeven daysMeasures ambulatory activity for seven days
Resting blood pressureDay 1Standard resting systolic and diastolic blood pressure
Ankle-brachial indexDay 1Measures atherosclerosis in the lower extremities by dividing the systolic blood pressure at the ankle with the systolic blood pressure of the arm.
Ambulatory 24-hour blood pressureDay 1Monitors systolic and diastolic blood pressures every 30 minutes over 24 hours
ElectrocardiographyDay 1Standard 12-lead ECG recording
24-hour Holter-ECGDay 1Monitors the heart activity
Advanced glycation endproduct (AGE)Day 1Measures AGE in the skin
SpirometryDay 1Dynamic spirometry
Gas diffusing capacity (DLCO)Day 1Measures diffusing capacity of the lungs using the single breath method
Impulse oscillometryDay 1Measures lung mechanics
Arterial stiffnessDay 1Estimated by pulse wave analysis
Waist circumferenceDay 1Recorded in centimeters in supine position using a flexible measure tape
ErythrocytesDay 1Analysis of venous blood sample for erythrocytes level
Erythrocyte volume fraction (EVF)Day 1Analysis of venous blood sample for EVF level
LeukocytesDay 1Analysis of venous blood sample for leukocytes level
TrombocytesDay 1Analysis of venous blood sample for trombocytes level
CreatinineDay 1Analysis of venous blood sample for Creatinine level
UrateDay 1Analysis of venous blood sample for Urate level
QuestionnaireDay 1self-reported health, lifestyle, social determinants, living conditions and medical history

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026