Trial Outcomes & Findings for Effect of Raised CBF During CEA on Cognition in DM Patients (NCT NCT00597545)

NCT ID: NCT00597545

Last Updated: 2015-07-13

Results Overview

Battery of neuropsychometric tests to evaluate a variety of cognitive functions.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Post-operatively at 1 day
• Results posted on: 2015-07-13

Participant Flow

Participant milestones

Measure	Conventional Shunt Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.	Prophylactic Shunt Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.
Overall Study STARTED	4	6
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Raised CBF During CEA on Cognition in DM Patients

Baseline characteristics by cohort

Measure	Conventional Shunt n=4 Participants Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.	Prophylactic Shunt n=6 Participants Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants	69 years n=7 Participants	68.7 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-operatively at 1 day

Battery of neuropsychometric tests to evaluate a variety of cognitive functions.

Outcome measures

Measure	Conventional Shunt n=4 Participants Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.	Prophylactic Shunt n=6 Participants Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one. Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.
Number of Participants With Improved Neuropsychometric Changes	1 participants	2 participants

Adverse Events

Conventional Shunt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prophylactic Shunt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric J Heyer

Columbia University

Phone: 212-305-9072

Email: ejh3@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place