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The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment (SPICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515122
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Skane University Hospital
Information provided by (Responsible Party):
Jan Lexell, Lund University

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.

Condition or disease
Spinal Cord Injuries Cardiovascular Diseases Pulmonary Disease Autonomic Dysfunction

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.


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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Persons with Spinal cord injury (SCI)
The total population of a specified group of persons with traumatic SCI will be invited to participate.
Matched control group
A matched control group of the general population at a ratio of 3-4 to each person with SCI will be recruited from the Swedish Cardiopulmonary and Bioimage Study.



Primary Outcome Measures :
  1. Coronary artery calcium score [ Time Frame: 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.

  2. Intima media thickness in the carotid arteries [ Time Frame: Day 1 ]
    Ultrasound of carotid arteries to measure intima media thickness

  3. Assesses atherosclerosis in the coronary arteries [ Time Frame: Day 1 ]
    Coronary CT Angiography

  4. Prevalence of structural changes in the lung tissue [ Time Frame: Day 1 ]
    High resolution CT scan

  5. Ectopic fat distribution [ Time Frame: Day 1 ]
    CT body composition of epicardium, liver, abdomen and muscle

  6. Heart rate response to deep breathing [ Time Frame: 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.

  7. Orthostatic blood pressure [ Time Frame: Day 1 ]
    Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.

  8. Plaques in the carotid arteries [ Time Frame: Day 1 ]
    Ultrasound of carotid arteries to measure and characterize plaques.


Secondary Outcome Measures :
  1. Questionnaire [ Time Frame: Day 1 ]
    self-reported health, lifestyle, social determinants, living conditions and medical history

  2. Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) [ Time Frame: Day 1 ]
    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

  3. Sense of Coherence Scale (SOC-13) [ Time Frame: Day 1 ]
    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.

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 1 ]
    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.

  5. Spinal Cord Independence Measure (SCIM III) [ Time Frame: Day 1 ]
    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.

  6. Modified Ashworth Scale [ Time Frame: Day 1 ]
    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.

  7. American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: Day 1 ]
    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.

  8. Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) [ Time Frame: Day 1 ]
    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.

  9. Total cholesterol [ Time Frame: Day 1 ]
    Analysis of venous blood sample for total cholesterol levels

  10. High density lipoproteins (HDL) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for total HDL-levels

  11. Low density lipoproteins (LDL) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for LDL-levels

  12. Triglycerides [ Time Frame: Day 1 ]
    Analysis of venous blood sample for triglycerides levels

  13. Fasting plasma glucose [ Time Frame: Day 1 ]
    Analysis of venous blood sample for fasting plasma glucose level

  14. Glycated hemoglobin (HbA1c) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for HbA1c level

  15. high sensitive C-reactive protein (hsCRP) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for hsCRP level

  16. Cystatin C [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Cystatin C level

  17. Creatinine [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Creatinine level

  18. Urate [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Urate level

  19. Hemoglobin [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Hemoglobin level

  20. Erythrocytes [ Time Frame: Day 1 ]
    Analysis of venous blood sample for erythrocytes level

  21. Erythrocyte volume fraction (EVF) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for EVF level

  22. Leukocytes [ Time Frame: Day 1 ]
    Analysis of venous blood sample for leukocytes level

  23. Trombocytes [ Time Frame: Day 1 ]
    Analysis of venous blood sample for trombocytes level

  24. Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Erc-MCH level

  25. Erythrocytes Mean Corpuscular Volume (Erc-MCV) [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Erc-MCV level

  26. Neutrophils [ Time Frame: Day 1 ]
    Analysis of venous blood sample for neutrophils level

  27. Eosinophils [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Eosinophils level

  28. Basophils [ Time Frame: Day 1 ]
    Analysis of venous blood sample for Basophils level

  29. Lymphocytes [ Time Frame: Day 1 ]
    Analysis of venous blood sample for lymphocytes level

  30. Monocytes [ Time Frame: Day 1 ]
    Analysis of venous blood sample for monocytes level

  31. Absolute glomerular filtration rate (GFR) [ Time Frame: Day 1 ]
    Calculated absolute GFR from Cystatin C level, body height, body weight, age and gender.

  32. Body weight [ Time Frame: Day 1 ]
    Recorded in kilograms with a portable scale for wheelchairs.

  33. Body height [ Time Frame: Day 1 ]
    Recorded in centimeters in supine position using a flexible measure tape

  34. Waist circumference [ Time Frame: Day 1 ]
    Recorded in centimeters in supine position using a flexible measure tape

  35. Hip circumference [ Time Frame: Day 1 ]
    Recorded in centimeters in supine position using a flexible measure tape

  36. Body mass index [ Time Frame: Day 1 ]
    Produced by dividing the body weight in kilograms with the body height in meters to the power of two

  37. Accelerometry [ Time Frame: Seven days ]
    Measures ambulatory activity for seven days

  38. Resting blood pressure [ Time Frame: Day 1 ]
    Standard resting systolic and diastolic blood pressure

  39. Ankle-brachial index [ Time Frame: Day 1 ]
    Measures atherosclerosis in the lower extremities by dividing the systolic blood pressure at the ankle with the systolic blood pressure of the arm.

  40. Ambulatory 24-hour blood pressure [ Time Frame: Day 1 ]
    Monitors systolic and diastolic blood pressures every 30 minutes over 24 hours

  41. Electrocardiography [ Time Frame: Day 1 ]
    Standard 12-lead ECG recording

  42. 24-hour Holter-ECG [ Time Frame: Day 1 ]
    Monitors the heart activity

  43. Advanced glycation endproduct (AGE) [ Time Frame: Day 1 ]
    Measures AGE in the skin

  44. Spirometry [ Time Frame: Day 1 ]
    Dynamic spirometry

  45. Gas diffusing capacity (DLCO) [ Time Frame: Day 1 ]
    Measures diffusing capacity of the lungs using the single breath method

  46. Impulse oscillometry [ Time Frame: Day 1 ]
    Measures lung mechanics

  47. Arterial stiffness [ Time Frame: Day 1 ]
    Estimated by pulse wave analysis

  48. Arterial stiffness [ Time Frame: Day 1 ]
    Measured using pulse wave velocity


Biospecimen Retention:   Samples With DNA
Serum, plasma-EDTA, plasma-Citrate plasma li-heparin, DNA EDTA-whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The total SCI population matching the inclusion criteria in Skåne, Sweden (n=38).
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515122


Locations
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Sweden
Rehabilitation medicine Research Group
Lund, Sweden
Sponsors and Collaborators
Lund University
Skane University Hospital
Investigators
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Principal Investigator: Jan Lexell, Professor Lund University

Publications:
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Responsible Party: Jan Lexell, Professor, Senior Consultant, Lund University
ClinicalTrials.gov Identifier: NCT03515122     History of Changes
Other Study ID Numbers: 2017-0765
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan Lexell, Lund University:
Epidemiology
Rehabilitation
Clinical protocols
Middle aged
Additional relevant MeSH terms:
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Spinal Cord Injuries
Autonomic Nervous System Diseases
Primary Dysautonomias
Wounds and Injuries
Cardiovascular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System