Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autonomic Dysreflexia, Spinal Cord Injuries and Disorders (SCI/D), Cardiac Remodeling. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease
Overview
This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI/D (above Th6) who have AD and 24 individuals with low-level SCI/D (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling. All 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI/D population.
Primary outcome measures
- Left ventricular end-diastolic volume (ml) [Time frame: baseline]
Secondary outcome measures (4)
- Left ventricular mass (g) [Time frame: baseline]
- Left ventricular end systolic volume (ml) [Time frame: baseline]
- Left ventricular ejection fraction (%) [Time frame: baseline]
- B-type natriuretic peptide level (pg/ml) [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- adults aged 18 years or older
- long-term (>10 years), motor-complete SCI/D (AIS A and B)
- Group A (24 individuals): high-level (>Th6) SCI/D and autonomic dysreflexia
- Group B (24 individuals): low-level (<Th10) SCI/D without autonomic dysreflexia
- signed informed consent
Exclusion criteria
- congenital heart defects
- valvular disease(s)
- cardiomyopathy
- medium to severe arrhythmia
- myocardial infarction
- comorbidities causing morphologic heart changes including primary hypertension, aortic stenosis
- comorbidities causing arterial hypertension
- use of anti-hypertensive treatment
- smokers
- individuals after sacral deafferentation surgery
- pregnancy
- active implanted medical devices
- claustrophobia
- inability to comply with the measurement procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- Swiss Paraplegic Center — Nottwil
Identifiers
NCT: NCT07456722 · 2024-20