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

NCT00123539 | Terminated

• 2 other identifiers: 237R01HL064600
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease; Cardiovascular Diseases; Heart Diseases; Neurologic Manifestations

Outcome Measures

Primary Outcomes (3)

• Neurocognitive function (measured 4 to 6 weeks after surgery)

• Cognitive function

• Quality of life (measured 6 months after surgery)

Interventions

Estrogen Replacement Therapy DRUG

Surgery PROCEDURE

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Stearns JD, Davila-Roman VG, Barzilai B, Thompson RE, Grogan KL, Thomas B, Hogue CW Jr. Prognostic value of troponin I levels for predicting adverse cardiovascular outcomes in postmenopausal women undergoing cardiac surgery. Anesth Analg. 2009 Mar;108(3):719-26. doi: 10.1213/ane.0b013e318193fe73.

  PMID: 19224775 DERIVED

• Hogue CW, Fucetola R, Hershey T, Freedland K, Davila-Roman VG, Goate AM, Thompson RE. Risk factors for neurocognitive dysfunction after cardiac surgery in postmenopausal women. Ann Thorac Surg. 2008 Aug;86(2):511-6. doi: 10.1016/j.athoracsur.2008.04.058.

  PMID: 18640325 DERIVED

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Heart Diseases; Neurologic Manifestations

Interventions

Estrogen Replacement Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Replacement Therapy; Drug Therapy; Therapeutics

Study Officials

• Charles W. Hogue, Jr., MD

  Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 25, 2005
• Study Start: June 1, 2001
• Study Completion: August 1, 2005
• Last Updated: July 29, 2016

Record last verified: 2007-12

Locations

US (1)