The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment

Cardiovascular Diseases Clinical Trial

— SPICA  

Official title:

The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515122
• Other study ID #: 2017-0765
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Cardiovascular Diseases
• Lung Diseases
• Primary Dysautonomias
• Pulmonary Disease
• Spinal Cord Injuries
• Wounds and Injuries

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