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The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be <5%.
This study will only be evaluating clinical care and no interventions will be done specifically for this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic carotid stenosis with low risk features | 50-99% symptomatic carotid stenosis with low clinical or radiologic risk features (see inclusion criteria) Patients will receive intensive medical therapy, including dual antiplatelet therapy, high potency statins, BP control, and lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive medical therapy | Other | Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | ipsilateral to carotid stenosis, with radiologic confirmation | within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements | within 12 months |
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Inclusion Criteria:
In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk
Clinical Reduced Stroke RISK:
Radiologic Reduced Stroke RISK:
Exclusion Criteria:
Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration <6 minutes
Alcohol and substance abuse within the prior 24 months
Clinically significant bleeding diathesis (platelet count <100K, prothrombin time >14 seconds)
Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)
Left ventricular ejection fraction <20%
Known allergy or intolerance to aspirin or clopidogrel
Life expectancy less than 12 months
Moderate/severe dementia (Mini-mental or MOCA score <22
Modified Rankin score of >4
Nonatherosclerotic cause of carotid stenosis
Most recent symptomatic event >180 days from the time of enrollment
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Patients with 50-99% symptomatic carotid stenosis and low risk clinical or radiologic features
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| Name | Affiliation | Role |
|---|---|---|
| Seemant Chaturvedi, MD | School of Medicine, University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19850894 | Result | King A, Markus HS. Doppler embolic signals in cerebrovascular disease and prediction of stroke risk: a systematic review and meta-analysis. Stroke. 2009 Dec;40(12):3711-7. doi: 10.1161/STROKEAHA.109.563056. Epub 2009 Oct 22. | |
| 30588374 | Result | Chaturvedi S. Treatment of a hot carotid: More fuel is needed to clarify the best treatments. Neurol Clin Pract. 2018 Dec;8(6):466-467. doi: 10.1212/CPJ.0000000000000561. No abstract available. |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush Medical Center | Chicago | Illinois | 60612 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Baylor Medicine | Houston | Texas | 77030 | United States |
| Calgary Health Sciences Center | Calgary | Alberta | Canada |
| University of Alberta | Edmonton | Alberta | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| University of Manitoba | Winnipeg | MN | Canada |
| Northern Ontario School of Medicine | Greater Sudbury | Ontario | Canada |
| Western University/London Health Sciences Center | London | Ontario | Canada |
| CHUM | Montreal | Quebec | H2X 0C1 | Canada |
| 30954372 | Result | Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4. |
| 15043958 | Result | Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1. |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |
| D002545 | Brain Ischemia |
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