Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123539
Status:
TERMINATED
Last Update Posted:
2016-07-29
First Post:
2005-07-21
Brief Title:
Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Estradiol for Neurocognitive Dysfunction After CABG
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after coronary artery bypass graft CABG surgery
Detailed Description:
BACKGROUND
Women undergoing CABG surgery have a higher operative mortality rate longer hospitalizations and higher hospital costs compared with men A large proportion of this excess morbidity and mortality of surgery for women is due to perioperative neurologic injury Estrogen has been consistently shown to reduce the extent of neurologic injury in a variety of in vitro and animal experimental stroke models These data together strongly suggest that the higher risk for perioperative neurologic complications for elderly women may relate to their estrogen deficient state
DESIGN NARRATIVE
This randomized placebo controlled study will test the hypothesis that perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after CABG surgery Three hundred thirty-four women undergoing CABG surgery will be prospectively randomized to receive either 17 beta-estradiol or placebo in a double-blind fashion beginning the day before surgery and continuing for 5 days after surgery Patients will be assessed for neurocognitive dysfunction which is the most common manifestation of neurologic injury from cardiac surgery Neurocognitive testing will be performed 1 to 2 days before surgery 4 to 6 weeks postoperatively and 6 months after surgery The primary endpoint will be neurocognitive function 4 to 6 weeks after surgery for women who received 17 beta- estradiol compared with placebo perioperatively The trial will also evaluate the importance of postoperative cognitive decline on measures of cognitive function and quality of life 6 months after surgery and whether perioperative 17 beta-estradiol treatment improves these outcomes
Women undergoing CABG surgery have a higher operative mortality rate longer hospitalizations and higher hospital costs compared with men A large proportion of this excess morbidity and mortality of surgery for women is due to perioperative neurologic injury Estrogen has been consistently shown to reduce the extent of neurologic injury in a variety of in vitro and animal experimental stroke models These data together strongly suggest that the higher risk for perioperative neurologic complications for elderly women may relate to their estrogen deficient state
DESIGN NARRATIVE
This randomized placebo controlled study will test the hypothesis that perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after CABG surgery Three hundred thirty-four women undergoing CABG surgery will be prospectively randomized to receive either 17 beta-estradiol or placebo in a double-blind fashion beginning the day before surgery and continuing for 5 days after surgery Patients will be assessed for neurocognitive dysfunction which is the most common manifestation of neurologic injury from cardiac surgery Neurocognitive testing will be performed 1 to 2 days before surgery 4 to 6 weeks postoperatively and 6 months after surgery The primary endpoint will be neurocognitive function 4 to 6 weeks after surgery for women who received 17 beta- estradiol compared with placebo perioperatively The trial will also evaluate the importance of postoperative cognitive decline on measures of cognitive function and quality of life 6 months after surgery and whether perioperative 17 beta-estradiol treatment improves these outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL064600 | NIH | None | httpsreporternihgovquickSearchR01HL064600 |