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The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.
The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.
The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Shunt | Active Comparator | These patients are called routine as the routine method of carotid endarterectomy is used. |
|
| Selective Shunt | Active Comparator | These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid endarterectomy with routine shount | Procedure |
| ||
| Carotid endarterectomy with selective shunt |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Perioperative Complications Between Selective vs. Routine Shunting. | perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure. | Within 30 days of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali F AbuRhama, M.D. | CAMC Medical Staff - with admitting privileges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| (Vascular Center of Excellence) | Charleston | West Virginia | 25304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Shunt | Routine method of CEA |
| FG001 | Selective Shunt | Selective method if CEA with based Systolic pressure 40 mmHg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Shunt | routine methods of CEA |
| BG001 | Selective Shunt | Selective method if CEA with based Systolic pressure 40 mmHg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Perioperative Complications Between Selective vs. Routine Shunting. | perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure. | Posted | Number | Participants | Within 30 days of enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Routine Shunt | routine methods of CEA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ali Fawazi AbuRahma MD | Vascular center of excellence (CAMC medical staff-with admitting privileges) | 304-388-9973 |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Procedure |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Selective Shunt | Selective method if CEA with based Systolic pressure 40 mmHg | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |