The Effect of Remote Ischemic Conditioning in Patients Wi... | NCT05164185

Studies
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

NCT05164185

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Dec 20, 2021Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Hypercholesteremia
Endothelial Dysfunction

Interventions

Remote ischemic conditioning

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2020Actual

Primary Completion Date

Nov 10, 2021Actual

Completion Date

Nov 10, 2021Actual

First Submitted Date

Dec 7, 2021

First Submission Date that Met QC Criteria

Dec 7, 2021

First Posted Date

Dec 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2021

Last Update Posted Date

Dec 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flow-mediated vasodilatation/endothelium-dependent vasodilatation	A ultrasound based technic for evaluation of endothelial function	20 min post-reperfusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Pernow, Prof	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet, Karolinska University Hospital		Stockholm		17176	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

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Browse Branches

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