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Trial record 36 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization

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ClinicalTrials.gov Identifier: NCT03786666
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : January 1, 2019
Sponsor:
Collaborators:
The First Affiliated Hospital of Soochow University
First Hospital of Jilin University
The First Affiliated Hospital of Shanxi Medical University
The Second People's Hospital of Liaocheng
Liaocheng Brains Hospital
LanZhou University
First Hospital of China Medical University
Dalian Municipal Central Hospital
Peking University Third Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Henan Provincial Hospital
Shengli Oilfield Hospital
Zhengzhou First People’s Hospital
Weihai Municipal Hospital
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief Summary:

The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA.

2) To establish the carotid artery recanalization strategies based on the evaluation results of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD (transcranial color coded sonography/transcranial doppler).

3) To compare the success rate and the incidence of restenosis between CEA and carotid artery stenting.


Condition or disease Intervention/treatment
Stroke Procedure: Carotid artery recanalization CEA or carotid artery stenting

Detailed Description:

In this study, a total of 1000-1200 patients with carotid artery severe (70-99%) stenosis or occlusion who received either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of carotid artery and intracranial artery. In addition, patients are to be followed up by ultrasound 1 week, 3 month, 6month and 1 year after recanalization.

  1. Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Stroke Prevention Engineering Committee, the National Health Commission of China in 2015. The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by CDFI and TCCS/TCD.
  2. Radiology examination procedures: Before recanalization, enrolled patients receive MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion. One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage and newly cerebral infarction.
  3. The data collected in this study including:

1) The general information of enrolled subjects, which include age, gender, resident address and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia, diabetes mellitus and smoking.

2. The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day after recanalization. The secondary endpoints are the re-current cerebral artery events and the occurence of restenosis during the at least 1 year follow-up period.

4. Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis.

1) Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.

2) The Chi-square test are used to compare the success rate of stenting and CEA. The Cox regression analysis are used to compare the restenosis rate of stenting and CEA.

3) A P<0.05 was considered statistically significance. 5. Quality assurance plan:

  1. The medical centers implement the projects are the stroke center awarded by the Stroke Prevention Engineering Committee, the National Health Commission of China. The medical centers have the instruments required in this study.
  2. Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by the Stroke Prevention Engineering Committee, the National Health Commission of China and obtained excellent records.
  3. All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
  4. The project has the unique database and data input in uniform format.
  5. There are specific staffs to check the accuracy and completeness of data.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Ultrasound Evaluation of Atherosclerotic Plaques and the Success of Recanalization in Patients With Carotid Artery Stenosis and Occlusion
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Procedure: Carotid artery recanalization CEA or carotid artery stenting
    Carotid artery recanalization CEA or carotid artery stenting


Primary Outcome Measures :
  1. The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%. [ Time Frame: within 30-day after recanalization. ]
    The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%


Secondary Outcome Measures :
  1. the rate of re-current cerebral artery events and the occurence of restenosis [ Time Frame: during the at least 1 year follow-up period ]
    the rate of re-current cerebral artery events and the occurence of restenosis


Biospecimen Retention:   Samples Without DNA
Carotid artery plaques removed by CEA.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with carotid artery severe (70-99%) stenosis or occlusion, who needs recanalization by CEA or stenting.
Criteria

Inclusion Criteria:

  • 1) Patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA.

    2) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.

    3) Patient with complete imaging evaluation and can be followed up to at least 1 year.

Exclusion Criteria:

- 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al.

2) Patients with cerebral hemorrhage. 3) Pregnant


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786666


Contacts
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Contact: Yang Hua, MD 86-10-83198923 dryanghua99@163.com
Contact: Lingyun Jia, MD, PhD 86-10-83198923 lingyunjia2012@163.com

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Xuanwu Hospital, Beijing
The First Affiliated Hospital of Soochow University
First Hospital of Jilin University
The First Affiliated Hospital of Shanxi Medical University
The Second People's Hospital of Liaocheng
Liaocheng Brains Hospital
LanZhou University
First Hospital of China Medical University
Dalian Municipal Central Hospital
Peking University Third Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Henan Provincial Hospital
Shengli Oilfield Hospital
Zhengzhou First People’s Hospital
Weihai Municipal Hospital
Investigators
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Principal Investigator: Yang Hua, MD No.45 Changchun Road, Beijing,100053, China

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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03786666     History of Changes
Other Study ID Numbers: VUS-CAS
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuanwu Hospital, Beijing:
Stroke
Ischemia
Carotid artery Stenosis
CEA
Stenting
Ultrasound
Vulnerable plaque

Additional relevant MeSH terms:
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Carotid Stenosis
Plaque, Atherosclerotic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical