Stenoses, Carotid Artery
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDURECarotid endarterectomy with routine shount
PROCEDURECarotid endarterectomy with selective shunt
Sponsors
CAMC Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with a SP \>= 50 mmHg will be randomized to receive a shunt or not receive a shunt.
Exclusion criteria
* Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of \> 30%. * Finally, consented patients with a stump pressure of \<= 50 mm Hg will be excluded from the study and receive standard of care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Perioperative Complications Between Selective vs. Routine Shunting. | Within 30 days of enrollment | perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction \[MI\], or asymptomatic carotid thrombosis or congestive heart failure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAli F AbuRhama, M.D.
CAMC Medical Staff - with admitting privileges
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Routine Shunt routine methods of CEA | 98 |
| Selective Shunt Selective method if CEA with based Systolic pressure 40 mmHg | 102 |
| Total | 200 |
Baseline characteristics
| Characteristic | Total | Routine Shunt | Selective Shunt |
|---|---|---|---|
| Age, Continuous | 68.02 years STANDARD_DEVIATION 9.46 | 68.78 years STANDARD_DEVIATION 9.08 | 67.29 years STANDARD_DEVIATION 9.81 |
| Age, Customized >=65 years | 118 participants | 60 participants | 58 participants |
| Age, Customized Between 18 and 65 years | 82 participants | 38 participants | 44 participants |
| Region of Enrollment United States | 200 participants | 98 participants | 102 participants |
| Sex: Female, Male Female | 103 Participants | 50 Participants | 53 Participants |
| Sex: Female, Male Male | 97 Participants | 48 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 1 / 102 |
| other Total, other adverse events | 0 / 98 | 0 / 102 |
| serious Total, serious adverse events | 0 / 98 | 1 / 102 |
Outcome results
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.
Time frame: Within 30 days of enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Shunt | Overall Perioperative Complications Between Selective vs. Routine Shunting. | 7 Participants |
| Selective Shunt | Overall Perioperative Complications Between Selective vs. Routine Shunting. | 8 Participants |
p-value: <0.05Fisher Exact