Evaluation of cardiac microstructure with cardiac DTI Circulatory System
Conditions
Interventions
Single MRI scan for non-travelling volunteers
Single MRI scan for travelling volunteers at each site, over multiple sites
Non-travelling healthy volunteers will be identified, approached and recruite
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteer 2. Male or female; sites shall aim to recruit equal numbers, i.e. male (n = 6) / female (n = 6) 3. Age 18 to 65 years old 4. Body mass index (BMI) 18.5 to 29.9 kg/m2 5. For travelling volunteer study: Ability to travel independently between sites, and to have all scans done within 2 months from first scan; possession of valid documentation (e.g. passport and visa) to travel between sites with validity extending to at least 8 months following first MRI scan, and with passport no older than 10 years at time of last scan.
Exclusion criteria
Exclusion criteria: 1. Safety or clinical concerns precluding participation 2. Any history of health conditions that may affect the heart (e.g. hypertension, diabetes, arrhythmias, angina, myocardial, valve and vessel disease) 3. Pregnancy or breastfeeding, including suspected pregnancy 4. Claustrophobia that limits/prevents participants from remaining in the MRI scanner 5. Inability to lie flat on the scanner table 6. Physical frailty 7. Contraindications to MRI (some pacemakers, intraorbital debris, intraauricular implants, intracranial clips, etc) 8. Those who could be considered to have a particularly dependent relationship with an investigator, e.g. members of staff or students 9. Involvement with the research apart from volunteering 10. Any relevant health conditions precluding safe travel between sites within 2 2-month time frame (For travelling volunteer study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac DTI data including mean diffusivity, fractional anisotropy, helix angle and E2 angle. For non-travelling volunteers, these will be acquired at baseline. For travelling volunteers, these will be acquired at all travelling volunteer sites within 2 months of baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Signal-to-noise ratio and potential non-compliance of scans with the protocol collected during each scan | — |
Countries
Belgium, Denmark, England, France, Japan, Poland, Switzerland, United Kingdom, United States of America, Wales
Contacts
Public ContactKathryn Richards
Outcome results
None listed