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Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT05451030
Collaborator
(none)
122
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: remote ischemic preconditioning
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT): A Prospective, Randomized Controlled, Blind Outcome Evaluation, Multi-center Study
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
Jun 28, 2023
Anticipated Study Completion Date :
Jun 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: remote ischemic preconditioning

Device: remote ischemic preconditioning
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.
Sham Comparator: control group

Device: remote ischemic preconditioning
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in cerebral circulation time [pre-intervention]

Secondary Outcome Measures

  1. changes in contrast staining on brain computerized tomography after carotid artery stenting [1 hours and 24 hours after carotid artery stenting]

  2. changes in collateral scoring based on digital subtraction angiography [pre-intervention]

  3. occurence of hyperperfusion syndrome after carotid artery stenting [24 hours and 7 days after carotid artery stenting]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurology, General Hospital of Northern Theater Command Shenyang China 110016

Sponsors and Collaborators

  • General Hospital of Shenyang Military Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui-Sheng Chen, Head of Neurology, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier:
NCT05451030
Other Study ID Numbers:
  • Y (2022) 022
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic

Study Results

No Results Posted as of Jul 11, 2022