NCT05451030

Brief Summary

Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. The prospective, randomized controlled, blind outcome evaluation, multi-center study aimed to investigate the effect of remote ischemic preconditioning on cerebral circulation time in patients with severe carotid artery stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

July 5, 2022

Last Update Submit

March 6, 2023

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Changes in cerebral circulation time

    pre-intervention

Secondary Outcomes (3)

  • changes in contrast staining on brain computerized tomography after carotid artery stenting

    1 hours and 24 hours after carotid artery stenting

  • changes in collateral scoring based on digital subtraction angiography

    pre-intervention

  • occurence of hyperperfusion syndrome after carotid artery stenting

    24 hours and 7 days after carotid artery stenting

Study Arms (2)

remote ischemic preconditioning

EXPERIMENTAL
Device: remote ischemic preconditioning

control group

SHAM COMPARATOR
Device: remote ischemic preconditioning

Interventions

remote ischemic preconditioningDEVICE

The cuff of a pneumatic electronic auto-control device placed around the bilateral upper limbs was used to deliver the protocol: 5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), for a total procedure time of 50 minutes, twice daily from the first DSA to the day of carotid artery stenting.

control groupremote ischemic preconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older, regardless of gender;
  • patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
  • non-responsible vessel stenosis \<50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
  • first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
  • baseline modified Rankin Scale (mRS) ≤ 2 points.
  • signed the informed consent form.

You may not qualify if:

  • baseline mRS ≥ 3 points;
  • severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
  • spontaneous intracranial hemorrhage within 12 months;
  • previous severe stroke or myocardial infarction within 3 months;
  • active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
  • a large intracranial aneurysm that cannot be treated simultaneously;
  • severe insufficiency of vital organs such as the heart, lungs, liver and kidneys, or malignant tumors with an expected survival cycle of less than six months;
  • total occlusion of carotid artery without obvious cerebral ischemic symptoms
  • unable to tolerate anesthesia;
  • severe dementia;
  • uncontrolled hypertension ;
  • allergy to contrast media;
  • pregnancy;
  • being involved in studies with other drugs or instruments, etc;
  • contraindications to remote ischemic preconditioning, such as those with more severe soft tissue injuries, fractures or vascular injuries in the upper extremity, or peripheral vascular lesions in the distal upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

Related Publications (1)

  • Liu QY, Cui Y, Li W, Qiu J, Nguyen TN, Chen HS. Effect of remote ischemic preconditioning on cerebral circulation time in severe carotid artery stenosis: Results from the RIC-CCT trial. Cell Rep Med. 2024 Nov 19;5(11):101796. doi: 10.1016/j.xcrm.2024.101796. Epub 2024 Oct 28.

    PMID: 39471820DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 11, 2022

Study Start

June 28, 2022

Primary Completion

March 6, 2023

Study Completion

March 6, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

CN(1)