HypercholesteremiaNCT05164185
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
A study testing Remote ischemic conditioning in people with Hypercholesteremia and Endothelial Dysfunction, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesteremia, Endothelial Dysfunction
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2020to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Poorly treated FH, defined as LDL-C >5.5 mmol/L.
- Age, >18 and <65 years of age.
- A age matched control-group.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Karolinska University Hospital
Stockholm, 17176
About this study
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.
Read the 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.
- Conditions
- Hypercholesteremia, Endothelial Dysfunction
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemia reperfusion +remote ischemic conditioning | Active comparator | Active administration of short cykcles of ischemia. Receives: Procedure: Remote ischemic conditioning |
| Ischemia reperfusion +sham | Sham comparator | Placebo experiment without remote ischemic conditioning. Receives: Procedure: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated vasodilatation/endothelium-dependent vasodilatation
A ultrasound based technic for evaluation of endothelial function
Measured: 20 min post-reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start2 Sep 2020
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Pernow, Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164185
- Sponsor's protocol ID
- 2017/2096-32
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05164185
- Acronym / sponsor ID
- 2017/2096-32
- Conditions
- Hypercholesteremia, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemia reperfusion +remote ischemic conditioning | Active comparator | Procedure: Remote ischemic conditioningActive administration of short cykcles of ischemia. |
| Ischemia reperfusion +sham | Sham comparator | Procedure: Remote ischemic conditioningPlacebo experiment without remote ischemic conditioning. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Poorly treated FH, defined as LDL-C >5.5 mmol/L.
- Age, >18 and <65 years of age.
- A age matched control-group.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningBrief 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. | Procedure or surgery | Ischemia reperfusion +remote ischemic conditioning, Ischemia reperfusion +sham |
Primary outcome
Flow-mediated vasodilatation/endothelium-dependent vasodilatation
Time frame: 20 min post-reperfusion
A ultrasound based technic for evaluation of endothelial function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Hypercholesteremia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Pernow, Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Hypercholesteremia and Endothelial Dysfunction, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated vasodilatation/endothelium-dependent vasodilatation (time frame: 20 min post-reperfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.