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Trial record 7 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

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ClinicalTrials.gov Identifier: NCT03464851
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
CVR Global Inc.
Information provided by (Responsible Party):
Imad Bagh, M. D., The Cleveland Clinic

Brief Summary:
The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.

Condition or disease Intervention/treatment
Carotid Artery Stenosis Diagnostic Test: Carotid Stenotic Scan (CSS)

Detailed Description:

Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.

This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing.

Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound.

Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Group/Cohort Intervention/treatment
Unknown/Normal/Mild Disease
No prior carotid duplex study or known normal or mild disease in the ICAs (PSV <= 125 cm/sec)
Diagnostic Test: Carotid Stenotic Scan (CSS)

Placement of the CSS instrument on the carotid arteries to measure degree of stenosis

of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.


Known moderate or severe ICA Stenosis (PSV>125 cm/sec) Diagnostic Test: Carotid Stenotic Scan (CSS)

Placement of the CSS instrument on the carotid arteries to measure degree of stenosis

of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.


Known ICA Fibromuscular Dysplasia Diagnostic Test: Carotid Stenotic Scan (CSS)

Placement of the CSS instrument on the carotid arteries to measure degree of stenosis

of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.





Primary Outcome Measures :
  1. Comparison of CSS readings to conventional carotid artery duplex ultrasound [ Time Frame: Baseline ]
    Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis


Secondary Outcome Measures :
  1. Reproducibility of the CSS measurement [ Time Frame: Baseline ]
    Each CSS measurement will be repeated and the Intraclass Correlation Coefficient (ICC) will be calculated. The ICC in an index of the reliability of measurements from the same operator



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consistent of adult patients (> 18 years) presenting to the Cleveland Clinic Non-Invasive Vascular Laboratory for a scheduled carotid duplex ultrasound to evaluate for carotid artery disease or in follow-up of known ICA stenosis.
Criteria

Inclusion Criteria:

  • Outpatients age > 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.
  • Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV > 125 cm/sec) or occlusion of one or both ICAs
  • Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.

Exclusion Criteria:

  • Age < 18 years.
  • Hospitalized inpatients.
  • Inability to provide informed consent.
  • Prior history of carotid endarterectomy or carotid artery stent.
  • Prior neck surgery
  • Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.

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): NCT03464851


Contacts
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Contact: Imad Bagh, MD 2164444420 baghi@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Imad Bagh, MD    216-444-4420    baghi@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
CVR Global Inc.
Investigators
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Principal Investigator: Imad Bagh, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Imad Bagh, M. D., The Cleveland Clinic:
Study Protocol  [PDF] January 30, 2018
Informed Consent Form  [PDF] February 21, 2018


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Responsible Party: Imad Bagh, M. D., Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03464851     History of Changes
Other Study ID Numbers: IRB 18-126
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
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 Imad Bagh, M. D., The Cleveland Clinic:
carotid artery stenosis
plaque
carotid duplex
ultrasound
fibromsucular dysplasia
carotid atherosclerosis

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