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STAMCAR: A Prospective EC-IC Bypass Registry

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ClinicalTrials.gov Identifier: NCT02779803
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
American Association of Neurological Surgeons
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:

A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients, specifically, patients with carotid occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan). This subgroup includes:

  1. Hospitalized unstable patient with crescendo or postural TIA's
  2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy.

Condition or disease Intervention/treatment
Carotid Occlusion Procedure: EC-IC bypass

Detailed Description:

The registry is a multi-center international prospective registry. The patients will be prospectively followed for 24 months. Enrollment into the registry will take place over 3 years.

The primary objective is to collect prospective data on cerebral revascularization via superficial temporal artery (STA) to middle cerebral artery (MCA) for symptomatic carotid occlusion patients to determine if the procedure can be performed with less than 8% major peri-operative benchmark.

The secondary objective is to determine if cerebral revascularization via STA to MCA bypass will improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients over a 2 year period.

Clinical outcome in terms of resolved symptomatology, improved cerebrovascular hemodynamics, and cognitive status will be assessed. Short term and long term follow-up for a period of 24 months will include assessment of ipsilateral stroke or TIA rate, mortality, graft patency, assessment of MCA and bypass flow rates (if available), cognitive evaluation and quality of life evaluation.

Following enrollment baseline demographics and operative data will be collected. Follow-up will be performed at 1 month (m), 3m, 6m, 12m and 24m. Occurrence of new TIA or stroke will be determined. The patient's bypass patency, Qualitative Magnetic Resonance Angiogram (QMRA) flow data (site discretion) and NIHSS Score (NIHSS), Barthel Index (mBARTHEL), modified Rankin Scales (mRANKIN), EuroQOL, and the Montreal Cognitive Assessment (MoCA) with digital Clock Drawing (dCDT) will be recorded. An additional battery of neurocognitive tests will also be administered (Symbol Digit Modalities Test SDMT, Delis-Kaplan Executive Function System D-KEFS and TRAILS A/B).


Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: STAMCAR: A Prospective EC-IC Bypass Registry
Study Start Date : September 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Procedure: EC-IC bypass
    To determine if cerebral revascularization via STA to MCA bypass to improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients.


Primary Outcome Measures :
  1. Number of Patients with Ipsilateral Ischemic Stroke [ Time Frame: During surgery ]
  2. Number of Patients with Ipsilateral Ischemic Stroke [ Time Frame: Up to 30 days from surgery ]
  3. Number of Patients that experience Stroke [ Time Frame: After 30 days from surgery ]
  4. Number of Patients that experience Death [ Time Frame: After 30 days from surgery ]

Secondary Outcome Measures :
  1. Cerebral Hemodynamic Testing [ Time Frame: baseline, 3 months, 12 months ]
    Steal, Reduced reserve, normal (specific modality to be determined by site)

  2. Qualitative Magnetic Resonance Angiogram, Non-invasive Optimal Vessel Analysis Blood Flow Data [ Time Frame: baseline, 3 months, 12 months ]
    Site discretion; test assess the blood flow to the vessels in the brain

  3. Bypass Patency [ Time Frame: 3 months, 6 months, 12 months, 24 months ]
    Blood flow remains normal through the bypass

  4. EuroQOL-5 Dimensions [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    A standardized instrument for use as a measure of health outcomes and is applicable to a wide range of health conditions and treatments; provides a simple description profile and a single index value for health status.

  5. Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    The MoCA was designated as a rapid screening instrument for mild cognitive dysfunction; it assesses difference cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

  6. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    A systematic assessment tool that provides a quantitative measure of stroke-related neurological deficit; used to evaluate acuity of stroke patients, determine appropriate treatment, and predict patient outcomes.

  7. Modified Rankin Scale (mRankin) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    A 6(0-5) point disability scale that is used widely in both secondary prevention and acute stroke trials, including most of the thrombolysis trials that ranks the patient based upon the disability symptoms

  8. Modified Barthel Index (mBarthel) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. Can be used to monitor improvement in activities of daily living over time.

  9. Digital Clock Drawing Test (dCDT) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    The dCDT provides a novel technique to assess both cognitive and motor aspects of psychomotor speed within the same task and the potential to uncover subtleties of behavior not previously detected with non-digitized modes of data collection.

  10. Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    the D-KEFS Verbal Fluency Tests comprises of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures the examinee's ability to generate words fluently in an effortful, phonetic format (Letter Fluency), from overlearned concepts (Category Fluency), and while simultaneously shifting between overlearned concepts (Category Switching).

  11. Reitan Trails A/B Test [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 24 months ]
    Cognitive Assessment; assess the examinee's ability visual attention and task switching abilities; the trails should be made quickly as possible while trying to avoid mistakes.



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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 internal carotid artery or middle cerebral artery occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan).
Criteria

Inclusion Criteria:

  • Internal carotid artery or middle cerebral artery occlusion
  • Transient ischemic attack (TIA) or ischemic stroke in the ipsilateral hemisphere within 30 days in patients who are either

    • hospitalized unstable patients with crescendo or postural TIA's, OR
    • Multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy*
  • Evidence of ipsilateral impaired cerebrovascular reserve on physiological testing (e.g. Diamox challenge SPECT)
  • Modified Rankin Score (mRS) >3
  • Language comprehension intact
  • Age 18-85 years * failure of medical therapy must include at least failure on a regimen of antiplatelets and statins.

Exclusion Criteria:

  • Moya-moya syndrome
  • Known heart disease likely to cause cerebral ischemia

    • Prosthetic Valves
    • Atrial Fibrillation
    • Infective endocarditis
    • Left atrial or ventricular thrombus
    • Sick sinus syndrome
    • Cardiac myxoma
    • Cardiomyopathy with ejection fraction < 25%
  • Any condition likely to lead to death within 2 years
  • Pregnancy
  • Allergy or contraindication to aspirin
  • Uncontrolled diabetes mellitus (FBS > 300 mg%/16.7 mmol/L)
  • Uncontrolled hypertension (systolic BP>180, diastolic BP >110), other than induced for control of pressure dependent symptoms
  • Uncontrolled hypotension (diastolic BP <65)
  • Unstable angina

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): NCT02779803


Contacts
Contact: Carlos David, MD 781-744-8643 Carlos.A.David@lahey.org
Contact: Melissa Dunbar 781-744-8774 melissa.r.dunbar@lahey.org

Locations
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Jacques Morcos, MD    305-243-4675    jmorcos@med.miami.edu   
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Fady Charbel, MD    312-996-4842    fcharbel@uic.edu   
Contact: Sepideh Hanjani, MD    312-996-4842    hanjani@uic.edu   
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01803
Contact: Carlos David, MD    781-744-8643      
Contact: Melissa Dunbar    781-744-8774      
Sponsors and Collaborators
Lahey Clinic
American Association of Neurological Surgeons
Investigators
Principal Investigator: Carlos David, MD Lahey Hospital & Medical Center

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT02779803     History of Changes
Other Study ID Numbers: LCID: 2015-034
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided