Coronary DiseaseNCT00123539
Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
A study testing Estrogen Replacement Therapy and Surgery in people with Coronary Disease and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Coronary Disease, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Estrogen Replacement Therapy and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Estrogen Replacement Therapy, Surgery
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases, Heart Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen Replacement TherapyDrug
SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function (measured 4 to 6 weeks after surgery)
Cognitive function
Quality of life (measured 6 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startJun 2001
- Study completionAug 2005
Why it stopped: DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 334 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Charles W. Hogue, Jr., MD, Principal investigator, Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123539
- Sponsor's protocol ID
- 237
- Other IDs
- R01HL064600
- Status last verified
- Dec 2007
- First submitted
- 21 Jul 2005
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
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.
PubMed 19224775Hogue 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.
PubMed 18640325
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol for Neurocognitive Dysfunction After CABG
- ClinicalTrials.gov ID
- NCT00123539
- Acronym / sponsor ID
- 237
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.
- Enrolment
- 334 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- Aug 2005 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogen Replacement Therapy | Drug | – |
| Surgery | Procedure or surgery | – |
Primary outcome
Neurocognitive function (measured 4 to 6 weeks after surgery)
Cognitive function
Quality of life (measured 6 months after surgery)
Results and safety
The study was stopped early (reason given: DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 19224775Stearns 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.
- Derived from this study: PubMed 18640325Hogue 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.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles W. Hogue, Jr., MD principal investigator
Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen Replacement Therapy and Surgery in people with Coronary Disease and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive function (measured 4 to 6 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123539, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.