The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

NCT05164185 | Completed

• 1 other identifier: 2017/2096-32
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesteremia; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Flow-mediated vasodilatation/endothelium-dependent vasodilatation

  A ultrasound based technic for evaluation of endothelial function

  20 min post-reperfusion

Study Arms (2)

Ischemia reperfusion +remote ischemic conditioning

ACTIVE COMPARATOR

Active administration of short cykcles of ischemia.

Procedure: Remote ischemic conditioning

Ischemia reperfusion +sham

SHAM COMPARATOR

Placebo experiment without remote ischemic conditioning.

Procedure: Remote ischemic conditioning

Interventions

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.

Ischemia reperfusion +remote ischemic conditioning; Ischemia reperfusion +sham

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Poorly treated FH, defined as LDL-C \>5.5 mmol/L.
• Age, \>18 and \<65 years of age.
• A age matched control-group.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Pernow, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 20, 2021
• Study Start: September 2, 2020
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)