Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Swiss Paraplegic Research, Nottwil
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Left ventricular end-diastolic volume (ml)
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •individuals after sacral deafferentation surgery
- •pregnancy
Arms & Interventions
AD+
Spinal Cord Injury, above Th6, AIS A or B, Autonomic Dysreflexia
AD-
Spinal Cord Injury, below Th10, AIS A or B, no Autonomic Dysreflexia
Outcomes
Primary Outcomes
Left ventricular end-diastolic volume (ml)
Time Frame: baseline
Left ventricular end-diastolic volume assessed by cardiac MRI
Secondary Outcomes
- Left ventricular mass (g)(baseline)
- Left ventricular end systolic volume (ml)(baseline)
- Left ventricular ejection fraction (%)(baseline)
- B-type natriuretic peptide level (pg/ml)(baseline)