Clinical trial NCT03515122: The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
Official title: The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Cardiovascular Diseases
Pulmonary Disease
Autonomic Dysfunction
Keywords: Epidemiology
Rehabilitation
Clinical protocols
Middle aged
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2018-05-03
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The total SCI population matching the inclusion criteria in Skåne, Sweden (n=38).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coronary artery calcium score
timeFrame: Day 1
measure: Intima media thickness in the carotid arteries
timeFrame: Day 1
measure: Assesses atherosclerosis in the coronary arteries
timeFrame: Day 1
measure: Prevalence of structural changes in the lung tissue
timeFrame: Day 1
measure: Ectopic fat distribution
timeFrame: Day 1
measure: Heart rate response to deep breathing
timeFrame: Day 1
measure: Orthostatic blood pressure
timeFrame: Day 1
measure: Plaques in the carotid arteries
timeFrame: Day 1
Secondary outcomes:
measure: Questionnaire
timeFrame: Day 1
measure: Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
timeFrame: Day 1
measure: Sense of Coherence Scale (SOC-13)
timeFrame: Day 1
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: Day 1
measure: Modified Ashworth Scale
timeFrame: Day 1
measure: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: Day 1
measure: Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI)
timeFrame: Day 1
measure: Total cholesterol
timeFrame: Day 1
measure: High density lipoproteins (HDL)
timeFrame: Day 1
measure: Low density lipoproteins (LDL)
timeFrame: Day 1
measure: Triglycerides
timeFrame: Day 1
measure: Fasting plasma glucose
timeFrame: Day 1
measure: Glycated hemoglobin (HbA1c)
timeFrame: Day 1
measure: high sensitive C-reactive protein (hsCRP)
timeFrame: Day 1
measure: Cystatin C
timeFrame: Day 1
measure: Creatinine
timeFrame: Day 1
measure: Urate
timeFrame: Day 1
measure: Hemoglobin
timeFrame: Day 1
measure: Erythrocytes
timeFrame: Day 1
measure: Erythrocyte volume fraction (EVF)
timeFrame: Day 1
measure: Leukocytes
timeFrame: Day 1
measure: Trombocytes
timeFrame: Day 1
measure: Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)
timeFrame: Day 1
measure: Erythrocytes Mean Corpuscular Volume (Erc-MCV)
timeFrame: Day 1
measure: Neutrophils
timeFrame: Day 1
measure: Eosinophils
timeFrame: Day 1
measure: Basophils
timeFrame: Day 1
measure: Lymphocytes
timeFrame: Day 1
measure: Monocytes
timeFrame: Day 1
measure: Absolute glomerular filtration rate (GFR)
timeFrame: Day 1
measure: Body weight
timeFrame: Day 1
measure: Body height
timeFrame: Day 1
measure: Waist circumference
timeFrame: Day 1
measure: Hip circumference
timeFrame: Day 1
measure: Body mass index
timeFrame: Day 1
measure: Accelerometry
timeFrame: Seven days
measure: Resting blood pressure
timeFrame: Day 1
measure: Ankle-brachial index
timeFrame: Day 1
measure: Ambulatory 24-hour blood pressure
timeFrame: Day 1
measure: Electrocardiography
timeFrame: Day 1
measure: 24-hour Holter-ECG
timeFrame: Day 1
measure: Advanced glycation endproduct (AGE)
timeFrame: Day 1
measure: Spirometry
timeFrame: Day 1
measure: Gas diffusing capacity (DLCO)
timeFrame: Day 1
measure: Impulse oscillometry
timeFrame: Day 1
measure: Arterial stiffness
timeFrame: Day 1
measure: Arterial stiffness
timeFrame: Day 1
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Rehabilitation medicine Research Group
Study officials:
affiliation: Lund University
name: Jan Lexell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devivo MJ. Epidemiology of traumatic spinal cord injury: trends and future implications. Spinal Cord. 2012 May;50(5):365-72. doi: 10.1038/sc.2011.178. Epub 2012 Jan 24.
citation: Groah SL, Charlifue S, Tate D, Jensen MP, Molton IR, Forchheimer M, Krause JS, Lammertse DP, Campbell M. Spinal cord injury and aging: challenges and recommendations for future research. Am J Phys Med Rehabil. 2012 Jan;91(1):80-93. doi: 10.1097/PHM.0b013e31821f70bc.
citation: Warburton DE, Eng JJ, Krassioukov A, Sproule S; the SCIRE Research Team. Cardiovascular Health and Exercise Rehabilitation in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2007 Summer;13(1):98-122. doi: 10.1310/sci1301-98.
citation: Schilero GJ, Radulovic M, Wecht JM, Spungen AM, Bauman WA, Lesser M. A center's experience: pulmonary function in spinal cord injury. Lung. 2014 Jun;192(3):339-46. doi: 10.1007/s00408-014-9575-8. Epub 2014 Apr 11.
citation: Bergstrom G, Berglund G, Blomberg A, Brandberg J, Engstrom G, Engvall J, Eriksson M, de Faire U, Flinck A, Hansson MG, Hedblad B, Hjelmgren O, Janson C, Jernberg T, Johnsson A, Johansson L, Lind L, Lofdahl CG, Melander O, Ostgren CJ, Persson A, Persson M, Sandstrom A, Schmidt C, Soderberg S, Sundstrom J, Toren K, Waldenstrom A, Wedel H, Vikgren J, Fagerberg B, Rosengren A. The Swedish CArdioPulmonary BioImage Study: objectives and design. J Intern Med. 2015 Dec;278(6):645-59. doi: 10.1111/joim.12384. Epub 2015 Jun 19.