San Francisco VA Medical Center
San Francisco, California, 94121, United States
NCT Number: NCT01606488
Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients greater than or equal to 65 years of age.
This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects scheduled for hip or knee replacement.
The investigators hypothesize that preoperative beta-amyloid plaques will predict postoperative cognitive decline.
This study is active but is not currently recruiting participants.
65 year and older
All sexes
Interventional
Phase 4
San Francisco, California, 94121, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan.
Other names: Florbetapir, Amyvid 18F-AV-45
Time frame: At the time of discharge (or at the latest on the 7th postoperative day)
Measured using comprehensive neurocognitive test battery
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured by obtaining blood sample
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using Heart Rate Variability (HRV)
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured by obtaining blood samples
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using patient medical records
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using the Richmond Agitation Sedation Scale (RASS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using patient medical records
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using patient medical records
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using comprehensive neurocognitive test battery
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using patient medical records
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using the Numerical Rating Scale
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using the Numerical Rating Scale
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Measured using the PTSD Checklist
University of California, San Francisco
Other
Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05574400
Alzheimer Disease, Brain Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT07673978
Cognition Disorders, Cognitive Dysfunction
Chongqing, Chongqing Municipality, China
View Trial DetailsNCT03147937
Autoimmune Diseases, Cognition Disorders
Toronto, Ontario, Canada
View Trial DetailsNCT04765488
Agitation, Emergence, Cognition Disorders
Moscow, Russia
View Trial Details