The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Primary Purpose
Hypercholesteremia, Endothelial Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesteremia
Eligibility Criteria
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.
Sites / Locations
- Karolinska Institutet, Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Ischemia reperfusion +remote ischemic conditioning
Ischemia reperfusion +sham
Arm Description
Active administration of short cykcles of ischemia.
Placebo experiment without remote ischemic conditioning.
Outcomes
Primary Outcome Measures
Flow-mediated vasodilatation/endothelium-dependent vasodilatation
A ultrasound based technic for evaluation of endothelial function
Secondary Outcome Measures
Full Information
NCT ID
NCT05164185
First Posted
December 7, 2021
Last Updated
December 7, 2021
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT05164185
Brief Title
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Official Title
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia, Endothelial Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ischemia reperfusion +remote ischemic conditioning
Arm Type
Active Comparator
Arm Description
Active administration of short cykcles of ischemia.
Arm Title
Ischemia reperfusion +sham
Arm Type
Sham Comparator
Arm Description
Placebo experiment without remote ischemic conditioning.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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 Outcome Measure Information:
Title
Flow-mediated vasodilatation/endothelium-dependent vasodilatation
Description
A ultrasound based technic for evaluation of endothelial function
Time Frame
20 min post-reperfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pernow, Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
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