Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery

Estradiol for Neurocognitive Dysfunction After CABG

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.

Study Overview

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.

Study Type

Interventional

Enrollment

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients whose scheduled procedure is CABG surgery OR
  • Patients whose scheduled procedure is isolated aortic surgery OR
  • Patients whose scheduled procedure is mitral valve surgery OR
  • Patients whose scheduled procedure is CABG combined with aortic or mitral valve surgery

Exclusion Criteria:

  • Patients having re-operations
  • Patients having combined carotid endarterectomy with CABG surgery
  • Patients having CABG with tricuspid valve surgery
  • Patients having mitral and aortic valvular surgery (with or without CABG surgery)
  • Elevation of liver function test before surgery or creatinine before surgery greater than 2 mg/dl
  • Emergency surgery
  • Severe cognitive impairment before surgery as indicated by clinical history and/or a score greater than 12 on the Short Blessed Dementia Screening Test (see d11)
  • Inability to attend outpatient visits
  • A history of venous thromboembolism
  • Unexplained vaginal bleeding
  • A history of breast cancer or personal history of endometrial cancer in the absence of hysterectomy
  • Estrogen use within 6 months of the surgery
  • Patient refusal to participate
  • Inability to speak and read English or visual impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cognitive function
Neurocognitive function (measured 4 to 6 weeks after surgery)
Quality of life (measured 6 months after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles W. Hogue, Jr., MD, Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion

December 7, 2022

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 25, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

December 1, 2007

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Estrogen Replacement Therapy

3
Subscribe