Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy (SERIC-CASCEA)

November 21, 2023 updated by: Yi Yang

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy: A Pilot, Randomized Controlled Trial

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥18 years, <80 years, regardless of sex;
  2. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
  3. Baseline mRS 0-2;
  4. Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;
  5. Signed and dated informed consent is obtained;

Exclusion Criteria:

  1. Evolving stroke;
  2. Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;
  3. Severe dementia;
  4. The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc;
  5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment);
  6. Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl));
  7. The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
  8. Pregnant or lactating women;
  9. He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
  10. Other conditions that the researchers think are not suitable for the group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RIC+CEA+Standard medical treatment
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.
Procedure: Remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
Placebo Comparator: Sham RIC+CEA+Standard medical treatment
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.
Procedure: Sham remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time Frame: 6 days
Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with cerebrovascular events, cardiovascular events or death.
Time Frame: 90±7 days
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
90±7 days
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time Frame: 6 days
Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
6 days
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time Frame: 6 days
Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.
6 days
Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.
Time Frame: 6 days
The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Investigators

  • Study Chair: Yi Yang, MD, PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 9, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERIC-CASCEA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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