The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Endothelial Dysfunction Clinical Trial

Official title:

The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164185
• Other study ID #: 2017/2096-32
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: November 10, 2021

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypercholesteremia
• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated vasodilatation/endothelium-dependent vasodilatation	A ultrasound based technic for evaluation of endothelial function	20 min post-reperfusion