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Completed

NCT Number: NCT05164185

The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Ischemic conditioning

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.

Primary outcomes

  1. Flow-mediated vasodilatation/endothelium-dependent vasodilatation

    Time frame: 20 min post-reperfusion

    A ultrasound based technic for evaluation of endothelial function

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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