Spinal Cord InjuriesSPICANCT03515122
The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
An observational study of Spinal Cord Injuries and Cardiovascular Diseases, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Cardiovascular Diseases, Pulmonary Disease
- How many people
- 125 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The total SCI population matching the inclusion criteria in Skåne, Sweden (n=38).
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Epidemiology, Rehabilitation, Clinical protocols, Middle aged
- Medical subject headings
- Spinal Cord Injuries, Cardiovascular Diseases, Lung Diseases, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Intima media thickness in the carotid arteries
Ultrasound of carotid arteries to measure intima media thickness
Measured: Day 1
Assesses atherosclerosis in the coronary arteries
Coronary CT Angiography
Measured: Day 1
Prevalence of structural changes in the lung tissue
High resolution CT scan
Measured: Day 1
Ectopic fat distribution
CT body composition of epicardium, liver, abdomen and muscle
Measured: Day 1
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.
Measured: Day 1
Orthostatic blood pressure
Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.
Measured: Day 1
Plaques in the carotid arteries
Ultrasound of carotid arteries to measure and characterize plaques.
Measured: Day 1
Secondary outcomes (48)
Questionnaire
self-reported health, lifestyle, social determinants, living conditions and medical history
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Total cholesterol
Analysis of venous blood sample for total cholesterol levels
Measured: Day 1
High density lipoproteins (HDL)
Analysis of venous blood sample for total HDL-levels
Measured: Day 1
Low density lipoproteins (LDL)
Analysis of venous blood sample for LDL-levels
Measured: Day 1
Triglycerides
Analysis of venous blood sample for triglycerides levels
Measured: Day 1
Fasting plasma glucose
Analysis of venous blood sample for fasting plasma glucose level
Measured: Day 1
Glycated hemoglobin (HbA1c)
Analysis of venous blood sample for HbA1c level
Measured: Day 1
high sensitive C-reactive protein (hsCRP)
Analysis of venous blood sample for hsCRP level
Measured: Day 1
Cystatin C
Analysis of venous blood sample for Cystatin C level
Measured: Day 1
Creatinine
Analysis of venous blood sample for Creatinine level
Measured: Day 1
Urate
Analysis of venous blood sample for Urate level
Measured: Day 1
Hemoglobin
Analysis of venous blood sample for Hemoglobin level
Measured: Day 1
Erythrocytes
Analysis of venous blood sample for erythrocytes level
Measured: Day 1
Erythrocyte volume fraction (EVF)
Analysis of venous blood sample for EVF level
Measured: Day 1
Leukocytes
Analysis of venous blood sample for leukocytes level
Measured: Day 1
Trombocytes
Analysis of venous blood sample for trombocytes level
Measured: Day 1
Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)
Analysis of venous blood sample for Erc-MCH level
Measured: Day 1
Erythrocytes Mean Corpuscular Volume (Erc-MCV)
Analysis of venous blood sample for Erc-MCV level
Measured: Day 1
Neutrophils
Analysis of venous blood sample for neutrophils level
Measured: Day 1
Eosinophils
Analysis of venous blood sample for Eosinophils level
Measured: Day 1
Basophils
Analysis of venous blood sample for Basophils level
Measured: Day 1
Lymphocytes
Analysis of venous blood sample for lymphocytes level
Measured: Day 1
Monocytes
Analysis of venous blood sample for monocytes level
Measured: Day 1
Absolute glomerular filtration rate (GFR)
Calculated absolute GFR from Cystatin C level, body height, body weight, age and gender.
Measured: Day 1
Body weight
Recorded in kilograms with a portable scale for wheelchairs.
Measured: Day 1
Body height
Recorded in centimeters in supine position using a flexible measure tape
Measured: Day 1
Waist circumference
Recorded in centimeters in supine position using a flexible measure tape
Measured: Day 1
Hip circumference
Recorded in centimeters in supine position using a flexible measure tape
Measured: Day 1
Body mass index
Produced by dividing the body weight in kilograms with the body height in meters to the power of two
Measured: Day 1
Accelerometry
Measures ambulatory activity for seven days
Measured: Seven days
Resting blood pressure
Standard resting systolic and diastolic blood pressure
Measured: Day 1
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.
Measured: Day 1
Ambulatory 24-hour blood pressure
Monitors systolic and diastolic blood pressures every 30 minutes over 24 hours
Measured: Day 1
Electrocardiography
Standard 12-lead ECG recording
Measured: Day 1
24-hour Holter-ECG
Monitors the heart activity
Measured: Day 1
Advanced glycation endproduct (AGE)
Measures AGE in the skin
Measured: Day 1
Spirometry
Dynamic spirometry
Measured: Day 1
Gas diffusing capacity (DLCO)
Measures diffusing capacity of the lungs using the single breath method
Measured: Day 1
Impulse oscillometry
Measures lung mechanics
Measured: Day 1
Arterial stiffness
Estimated by pulse wave analysis
Measured: Day 1
Arterial stiffness
Measured using pulse wave velocity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start15 Nov 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Jan Lexell, Lund University
- Investigators
- Jan Lexell, Professor, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515122
- Sponsor's protocol ID
- 2017-0765
- Acronym
- SPICA
- Status last verified
- May 2019
- First submitted
- 20 Mar 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22270188Groah 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.
PubMed 21681060Warburton 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.
PubMed 22719205Schilero 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.
PubMed 24723067Bergstrom 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.
PubMed 26096600Hill M, Jorgensen S, Engstrom G, Lexell J. Cardiometabolic factors in middle-aged people with long-term cervical and upper thoracic spinal cord injuries. J Spinal Cord Med. 2026 Aug 18:1-10. doi: 10.1080/10790268.2026.2709252. Online ahead of print.
PubMed 42612198Hill M, Jorgensen S, Engstrom G, Persson M, Platonov PG, Hamrefors V, Lexell J. Cardiovascular autonomic function in middle-aged people with long-term cervical and upper thoracic spinal cord injuries. J Spinal Cord Med. 2025 May;48(3):447-460. doi: 10.1080/10790268.2024.2403791. Epub 2024 Oct 11.
PubMed 39392470
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
- ClinicalTrials.gov ID
- NCT03515122
- Acronym / sponsor ID
- SPICA / 2017-0765
- Keywords
- Epidemiology, Rehabilitation, Clinical protocols, Middle aged
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The total SCI population matching the inclusion criteria in Skåne, Sweden (n=38).
Key inclusion criteria (7 listed)
- Traumatic SCI
- SCI duration >5 years
- Neurological level of lesion C1-T6
- ASIA Impairment Scale A-C
- Resident in Skåne, Sweden
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Intima media thickness in the carotid arteries
Time frame: Day 1
Ultrasound of carotid arteries to measure intima media thickness
Assesses atherosclerosis in the coronary arteries
Time frame: Day 1
Coronary CT Angiography
Prevalence of structural changes in the lung tissue
Time frame: Day 1
High resolution CT scan
Ectopic fat distribution
Time frame: Day 1
CT body composition of epicardium, liver, abdomen and muscle
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.
Orthostatic blood pressure
Time frame: Day 1
Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.
Plaques in the carotid arteries
Time frame: Day 1
Ultrasound of carotid arteries to measure and characterize plaques.
48 secondary outcomes
Questionnaire
Time frame: Day 1
Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
Time frame: Day 1
Sense of Coherence Scale (SOC-13)
Time frame: Day 1
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
Spinal Cord Independence Measure (SCIM III)
Time frame: Day 1
Modified Ashworth Scale
Time frame: Day 1
American Spinal Injury Association (ASIA) Impairment Scale
Time frame: Day 1
Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI)
Time frame: Day 1
Total cholesterol
Time frame: Day 1
High density lipoproteins (HDL)
Time frame: Day 1
Low density lipoproteins (LDL)
Time frame: Day 1
Triglycerides
Time frame: Day 1
Fasting plasma glucose
Time frame: Day 1
Glycated hemoglobin (HbA1c)
Time frame: Day 1
high sensitive C-reactive protein (hsCRP)
Time frame: Day 1
Cystatin C
Time frame: Day 1
Creatinine
Time frame: Day 1
Urate
Time frame: Day 1
Hemoglobin
Time frame: Day 1
Erythrocytes
Time frame: Day 1
Erythrocyte volume fraction (EVF)
Time frame: Day 1
Leukocytes
Time frame: Day 1
Trombocytes
Time frame: Day 1
Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)
Time frame: Day 1
Erythrocytes Mean Corpuscular Volume (Erc-MCV)
Time frame: Day 1
Neutrophils
Time frame: Day 1
Eosinophils
Time frame: Day 1
Basophils
Time frame: Day 1
Lymphocytes
Time frame: Day 1
Monocytes
Time frame: Day 1
Absolute glomerular filtration rate (GFR)
Time frame: Day 1
Body weight
Time frame: Day 1
Body height
Time frame: Day 1
Waist circumference
Time frame: Day 1
Hip circumference
Time frame: Day 1
Body mass index
Time frame: Day 1
Accelerometry
Time frame: Seven days
Resting blood pressure
Time frame: Day 1
Ankle-brachial index
Time frame: Day 1
Ambulatory 24-hour blood pressure
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Background: PubMed 22270188Devivo 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.
- Background: PubMed 21681060Groah 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.
- Background: PubMed 22719205Warburton 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.
- Background: PubMed 24723067Schilero 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.
- Background: PubMed 26096600Bergstrom 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.
- Derived from this study: PubMed 42612198Hill M, Jorgensen S, Engstrom G, Lexell J. Cardiometabolic factors in middle-aged people with long-term cervical and upper thoracic spinal cord injuries. J Spinal Cord Med. 2026 Aug 18:1-10. doi: 10.1080/10790268.2026.2709252. Online ahead of print.
- Derived from this study: PubMed 39392470Hill M, Jorgensen S, Engstrom G, Persson M, Platonov PG, Hamrefors V, Lexell J. Cardiovascular autonomic function in middle-aged people with long-term cervical and upper thoracic spinal cord injuries. J Spinal Cord Med. 2025 May;48(3):447-460. doi: 10.1080/10790268.2024.2403791. Epub 2024 Oct 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Lexell, Professor principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Cardiovascular Diseases, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery calcium score (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515122, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.