The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Hypercholesteremia
• Interventions: Procedure: Remote ischemic conditioning

• Registration Number: NCT05164185
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2020-09-02
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Status Verified: 2021-12
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ischemia reperfusion +remote ischemic conditioning	Remote ischemic conditioning	Active administration of short cykcles of ischemia.
Ischemia reperfusion +sham	Remote ischemic conditioning	Placebo experiment without remote ischemic conditioning.

Primary Outcome Measures

Name	Time	Method
Flow-mediated vasodilatation/endothelium-dependent vasodilatation	20 min post-reperfusion	A ultrasound based technic for evaluation of endothelial function

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden