The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT05164185

Collaborator

(none)

Enrollment

Location

Arms

14.3

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesteremia Endothelial Dysfunction	Procedure: Remote ischemic conditioning	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

Actual Study Start Date :

Sep 2, 2020

Actual Primary Completion Date :

Nov 10, 2021

Actual Study Completion Date :

Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ischemia reperfusion +remote ischemic conditioning Active administration of short cykcles of ischemia.	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.
Sham Comparator: Ischemia reperfusion +sham Placebo experiment without remote ischemic conditioning.	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.

Arm

Intervention/Treatment

Active Comparator: Ischemia reperfusion +remote ischemic conditioning

Active administration of short cykcles of ischemia.

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.

Sham Comparator: Ischemia reperfusion +sham

Placebo experiment without remote ischemic conditioning.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: John Pernow, Prof, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT05164185

Other Study ID Numbers:

2017/2096-32

First Posted:

Dec 20, 2021

Last Update Posted:

Dec 20, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Dec 20, 2021