The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Conditions
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Hypercholesteremia, Endothelial Dysfunction

Intervention / Treatment
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* Procedure: Remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ischemia reperfusion +remote ischemic conditioning<br>Active administration of short cykcles of ischemia. | Procedure: Remote ischemic conditioning<br>* 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.<br>|
| Sham Comparator: Ischemia reperfusion +sham<br>Placebo experiment without remote ischemic conditioning. | Procedure: Remote ischemic conditioning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated vasodilatation/endothelium-dependent vasodilatation | A ultrasound based technic for evaluation of endothelial function | 20 min post-reperfusion |