Arterial StiffnessNCT04510974
RAAS and Arterial Stiffness in SCI
An observational study of Arterial Stiffness and Renin Angiotensin Aldosterone System, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Arterial Stiffness, Renin Angiotensin Aldosterone System, Orthostatic Hypotension
- What is being tested?
- Spinal Cord Injury
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2018to 1 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- Adult, Older adult
Study population: Outpatient individuals with SCI, flyers in town
Who may be able to join
- SCI participants:
- injured between C1-T1 and T6-T12
- wheelchair dependent
- AIS classification A, B or C
- Injured occurred more than 1 year ago
Who cannot join
- currently have an illness or infection
- current smoker of at least 1 year
- controlled or uncontrolled hypertension or diabetes mellitus
- Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
- cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orthostatic Blood Pressure and Arterial Stiffness in Persons With SCI: The Effect of RAAS System
The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.
Read the detailed description
The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. Arterial stiffness and blood pressure will be collected in the laying down position. A blood sample of norepinephrine and plasma renin will also be collected. The participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. Blood pressure and heart rate will be monitored at each angle. Another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.
- Conditions
- Arterial Stiffness, Renin Angiotensin Aldosterone System, Orthostatic Hypotension, Spinal Cord Injury, Hypotension
- Being tested
- Spinal Cord Injury
- Medical subject headings
- Hypotension, Orthostatic, Spinal Cord Injuries, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord InjuryOther
Spinal Cord Injury
| Study group | Role | What they receive |
|---|---|---|
| Cervical SCI | Ages between 21-70 years old Injured between C1-T1 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago Receives: Other: Spinal Cord Injury | |
| Thoracic SCI | Ages between 21-70 Injured between T6-T12 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago Receives: Other: Spinal Cord Injury | |
| Able-bodied Control | Ages between 21-70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity (m/s)
Determine average pulse wave velocity among the three groups.
Measured: 2 years
Secondary outcomes (3)
Systolic Blood Pressure (mmHg)
Determine differences in blood pressure among groups
Measured: 2 years
Plasma Renin (pg/ml)
Determine differences in plasma renin among the groups
Measured: 2 years
Norepinephrine (pg/ml)
Determine differences in plasma norepinephrine among the groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start30 Jun 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation, Seton Hall University
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510974
- Sponsor's protocol ID
- WEC-18-025
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2020
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic Blood Pressure and Arterial Stiffness in Persons With SCI: The Effect of RAAS System
- ClinicalTrials.gov ID
- NCT04510974
- Acronym / sponsor ID
- WEC-18-025
- Conditions
- Arterial Stiffness, Renin Angiotensin Aldosterone System, Orthostatic Hypotension, Spinal Cord Injury, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Foundation, Seton Hall University
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.
Detailed description
The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. Arterial stiffness and blood pressure will be collected in the laying down position. A blood sample of norepinephrine and plasma renin will also be collected. The participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. Blood pressure and heart rate will be monitored at each angle. Another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervical SCI | – | Other: Spinal Cord InjuryAges between 21-70 years old Injured between C1-T1 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago |
| Thoracic SCI | – | Other: Spinal Cord InjuryAges between 21-70 Injured between T6-T12 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago |
| Able-bodied Control | – | –Ages between 21-70 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatient individuals with SCI, flyers in town
Key inclusion criteria (5 listed)
- SCI participants:
- injured between C1-T1 and T6-T12
- wheelchair dependent
- AIS classification A, B or C
- Injured occurred more than 1 year ago
Key exclusion criteria (5 listed)
- currently have an illness or infection
- current smoker of at least 1 year
- controlled or uncontrolled hypertension or diabetes mellitus
- Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
- cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord InjurySpinal Cord Injury | Other | Cervical SCI, Thoracic SCI |
Primary outcome
Pulse Wave Velocity (m/s)
Time frame: 2 years
Determine average pulse wave velocity among the three groups.
3 secondary outcomes
Systolic Blood Pressure (mmHg)
Time frame: 2 years
Plasma Renin (pg/ml)
Time frame: 2 years
Norepinephrine (pg/ml)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arterial Stiffness and Renin Angiotensin Aldosterone System, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
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 5 inclusion and 5 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 20 Feb 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulse Wave Velocity (m/s) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.