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The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

NCT ID: NCT05164185

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2021-11-10

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.

Conditions

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Hypercholesteremia Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ischemia reperfusion +remote ischemic conditioning

Active administration of short cykcles of ischemia.

Group Type ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Ischemia reperfusion +sham

Placebo experiment without remote ischemic conditioning.

Group Type SHAM_COMPARATOR

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Pernow, Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2017/2096-32

Identifier Type: -

Identifier Source: org_study_id