The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Karolinska Institute

Status: Completed

Conditions: Endothelial Dysfunction; Hypercholesteremia

Treatments: Procedure: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05164185

2017/2096-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

36 participants in 2 patient groups

Ischemia reperfusion +remote ischemic conditioning

Active Comparator group

Description:

Active administration of short cykcles of ischemia.

Treatment:

Procedure: Remote ischemic conditioning

Ischemia reperfusion +sham

Sham Comparator group

Description:

Placebo experiment without remote ischemic conditioning.

Treatment:

Procedure: Remote ischemic conditioning