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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03515122
Other study ID # 2017-0765
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2017
Est. completion date June 30, 2018

Study information

Verified date May 2019
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Sweden Rehabilitation medicine Research Group Lund

Sponsors (2)

Lead Sponsor Collaborator
Lund University Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Bergström G, Berglund G, Blomberg A, Brandberg J, Engström G, Engvall J, Eriksson M, de Faire U, Flinck A, Hansson MG, Hedblad B, Hjelmgren O, Janson C, Jernberg T, Johnsson Å, Johansson L, Lind L, Löfdahl CG, Melander O, Östgren CJ, Persson A, Persson M, Sandström A, Schmidt C, Söderberg S, Sundström J, Toren K, Waldenström 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary artery calcium score 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. Day 1
Primary Intima media thickness in the carotid arteries Ultrasound of carotid arteries to measure intima media thickness Day 1
Primary Assesses atherosclerosis in the coronary arteries Coronary CT Angiography Day 1
Primary Prevalence of structural changes in the lung tissue High resolution CT scan Day 1
Primary Ectopic fat distribution CT body composition of epicardium, liver, abdomen and muscle Day 1
Primary Heart rate response to deep breathing Measures electrocardiography the activity of the autonomic nervous system based on the time and frequency domain indices of heart rate variability during deep breathing. Day 1
Primary Orthostatic blood pressure Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position. Day 1
Primary Plaques in the carotid arteries Ultrasound of carotid arteries to measure and characterize plaques. Day 1
Secondary Questionnaire self-reported health, lifestyle, social determinants, living conditions and medical history Day 1
Secondary Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Self-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 Day 1
Secondary Sense of Coherence Scale (SOC-13) To 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. Day 1
Secondary Hospital Anxiety and Depression Scale (HADS) Screening 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. Day 1
Secondary Spinal Cord Independence Measure (SCIM III) SCIM 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. Day 1
Secondary Modified Ashworth Scale Clinical examination of spasticity in specific muscles of the upper and lower extremities. The scale ranges from 0-4 with increasing scores indicating increased spasticity. Day 1
Secondary American Spinal Injury Association (ASIA) Impairment Scale Measures 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. Day 1
Secondary Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) Measures 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. Day 1
Secondary Total cholesterol Analysis of venous blood sample for total cholesterol levels Day 1
Secondary High density lipoproteins (HDL) Analysis of venous blood sample for total HDL-levels Day 1
Secondary Low density lipoproteins (LDL) Analysis of venous blood sample for LDL-levels Day 1
Secondary Triglycerides Analysis of venous blood sample for triglycerides levels Day 1
Secondary Fasting plasma glucose Analysis of venous blood sample for fasting plasma glucose level Day 1
Secondary Glycated hemoglobin (HbA1c) Analysis of venous blood sample for HbA1c level Day 1
Secondary high sensitive C-reactive protein (hsCRP) Analysis of venous blood sample for hsCRP level Day 1
Secondary Cystatin C Analysis of venous blood sample for Cystatin C level Day 1
Secondary Creatinine Analysis of venous blood sample for Creatinine level Day 1
Secondary Urate Analysis of venous blood sample for Urate level Day 1
Secondary Hemoglobin Analysis of venous blood sample for Hemoglobin level Day 1
Secondary Erythrocytes Analysis of venous blood sample for erythrocytes level Day 1
Secondary Erythrocyte volume fraction (EVF) Analysis of venous blood sample for EVF level Day 1
Secondary Leukocytes Analysis of venous blood sample for leukocytes level Day 1
Secondary Trombocytes Analysis of venous blood sample for trombocytes level Day 1
Secondary Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH) Analysis of venous blood sample for Erc-MCH level Day 1
Secondary Erythrocytes Mean Corpuscular Volume (Erc-MCV) Analysis of venous blood sample for Erc-MCV level Day 1
Secondary Neutrophils Analysis of venous blood sample for neutrophils level Day 1
Secondary Eosinophils Analysis of venous blood sample for Eosinophils level Day 1
Secondary Basophils Analysis of venous blood sample for Basophils level Day 1
Secondary Lymphocytes Analysis of venous blood sample for lymphocytes level Day 1
Secondary Monocytes Analysis of venous blood sample for monocytes level Day 1
Secondary Absolute glomerular filtration rate (GFR) Calculated absolute GFR from Cystatin C level, body height, body weight, age and gender. Day 1
Secondary Body weight Recorded in kilograms with a portable scale for wheelchairs. Day 1
Secondary Body height Recorded in centimeters in supine position using a flexible measure tape Day 1
Secondary Waist circumference Recorded in centimeters in supine position using a flexible measure tape Day 1
Secondary Hip circumference Recorded in centimeters in supine position using a flexible measure tape Day 1
Secondary Body mass index Produced by dividing the body weight in kilograms with the body height in meters to the power of two Day 1
Secondary Accelerometry Measures ambulatory activity for seven days Seven days
Secondary Resting blood pressure Standard resting systolic and diastolic blood pressure Day 1
Secondary Ankle-brachial index Measures atherosclerosis in the lower extremities by dividing the systolic blood pressure at the ankle with the systolic blood pressure of the arm. Day 1
Secondary Ambulatory 24-hour blood pressure Monitors systolic and diastolic blood pressures every 30 minutes over 24 hours Day 1
Secondary Electrocardiography Standard 12-lead ECG recording Day 1
Secondary 24-hour Holter-ECG Monitors the heart activity Day 1
Secondary Advanced glycation endproduct (AGE) Measures AGE in the skin Day 1
Secondary Spirometry Dynamic spirometry Day 1
Secondary Gas diffusing capacity (DLCO) Measures diffusing capacity of the lungs using the single breath method Day 1
Secondary Impulse oscillometry Measures lung mechanics Day 1
Secondary Arterial stiffness Estimated by pulse wave analysis Day 1
Secondary Arterial stiffness Measured using pulse wave velocity Day 1
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