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

This study has been terminated.
(DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00123539
First received: July 21, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Neurologic Manifestations
Drug: Estrogen Replacement Therapy
Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Estradiol for Neurocognitive Dysfunction After CABG

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Neurocognitive function (measured 4 to 6 weeks after surgery)
  • Cognitive function
  • Quality of life (measured 6 months after surgery)

Estimated Enrollment: 334
Study Start Date: June 2001
Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123539

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Principal Investigator: Charles W. Hogue, Jr., MD Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles W. Hogue, MD, The Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier: NCT00123539     History of Changes
Other Study ID Numbers: 237, R01 HL64600
Study First Received: July 21, 2005
Last Updated: December 17, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Neurologic Manifestations
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Nervous System Diseases
Signs and Symptoms
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014