Endothelial Dysfunction, Hypercholesteremia
Conditions
Brief summary
There is an on-going discussion weather remote ischemic conditioning (RIC) is effective in limiting the damage of reperfusion injury in STEMI patients. The results from recent RCTs have been variable and most have not shown convincing positive results when analyzing hard endpoints. Hence, there is a great need to evaluate the impact of comorbidities on the effectiveness of RIC. Therefore, we have designed a study to evaluate the impact of hypercholesterolemia on the RIC response by evaluating ischemia-induced endothelial dysfunction. Aim: To investigate the impact of hypercholesterolemia on the RIC response in counteracting ischemia-induced endothelial dysfunction.
Detailed description
Study population: We plan to include 12 poorly controlled/newly diagnosed subjects with familiar hypercholesterolemia (FH) and 12 age-matched control subjects. Inclusion criteria (FH subjects) * Poorly treated FH, defined as LDL-C \>5.5 mmol/L. * Age, \>18 and \<65 years of age. Exclusion criteria * Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure. * Unwillingness to participate. * Concurrently participating in another interventional trial. Main exposure: Remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb. Comparision group: Cross over design, patients preform the protocol twice, once with sham and once with RIC. Also a group of healthy matched controls will be recruited. Outcome: Change in FMD after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of either sham or RIC. Design: Randomized interventional cross-over.
Interventions
PROCEDURERemote ischemic conditioning
Brief cycles of ischemia to a limb. A blood pressure cuff was placed around the right thigh and inflated to 200 mmHg for 4 cycles of 5 minutes.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Poorly treated FH, defined as LDL-C \>5.5 mmol/L. * Age, \>18 and \<65 years of age. * A age matched control-group.
Exclusion criteria
* Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure. * Any condition which interfere with the outcome recording for example atrial fibrillation. * Unwillingness to participate. * Concurrently participating in another interventional trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated vasodilatation/endothelium-dependent vasodilatation | 20 min post-reperfusion | A ultrasound based technic for evaluation of endothelial function |
Countries
Sweden
Outcome results
None listed