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Completed

NCT Number: NCT05451030

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Device

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.

Primary outcomes

  1. Changes in cerebral circulation time

    Time frame: pre-intervention

Secondary outcomes

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

    Time frame: 1 hours and 24 hours after carotid artery stenting

  2. changes in collateral scoring based on digital subtraction angiography

    Time frame: pre-intervention

  3. occurence of hyperperfusion syndrome after carotid artery stenting

    Time frame: 24 hours and 7 days after carotid artery stenting

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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