NCT05164185

The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesteremia
• Endothelial Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Remote 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.

Timeline

• Start date: 2020-09-02
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2021-12-20
• Last updated: 2021-12-20

Locations

1 site across 1 country: Sweden