Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282711
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2006-01-25
Brief Title:
The WOMEN Study What is the Optimal Method for Ischemia Evaluation in WomeN
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
The WOMEN Study What is the Optimal Method for Ischemia Evaluation in WomeNA Multi-Center Prospective Randomized Study to Establish the Optimal Method for Detection of CAD Risk in Women at an Intermediate-High Pre-Test Likelihood CAD
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 compare two types of exercise stress testing to find the best method for detecting heart disease in women
Detailed Description:
Coronary artery disease remains the leading cause of morbidity and mortality in women accounting for more than 250000 deaths per year While mortality rates have decreased significantly in men during the last several decades there has been little change for women Furthermore despite the high prevalence of ischemic heart disease IHD in women most clinical trials have focused on male cohorts resulting in a lack of data for women Their exclusion from clinical trials has been primarily due to the following 1 child- bearing potential 2 beyond the arbitrary age limits established for trials 3 frequent concomitant or advanced disease and 4 inhomogeneity within the study population
Extrapolation of the published clinical trial data predominately obtained in men for women is controversial due to differences in epidemiology of heart disease in women Treatment is often sought later in life and is usually accompanied by more advanced disease and co-morbidities which therefore impact survival In addition women more frequently have an absence of clinical symptoms or an atypical presentation making the diagnosis of coronary artery disease CAD challenging Furthermore women may also have their first manifestation of CAD as sudden death or acute myocardial infarction Therefore there is a clear need for the early identification of IHD in women so that treatments may be employed prior to having an advanced state of disease and higher risk for unfavorable outcomes
The optimal non-invasive test for evaluation of IHD in women is unknown A number of different modalities have been employed including exercise ECG stress testing 2-dimensional stress echocardiography single photon emission computerized tomography SPECT myocardial perfusion imaging and electron beam tomography Additionally the cohort of women for whom testing is performed is also ill defined
The most recent AHAACC guidelines suggest that ECG stress testing should be the preferred approach Supportive data for this recommendation are controversial as many of the studies examining the diagnostic value of ECG stress testing were largely performed in small cohorts of women and are dated These trials indicate that the diagnostic accuracy of stress testing is only fair sensitivity32-89 specificity41-68 A recent meta-analysis in 3874 women demonstrated modest sensitivity and specificity 62 and 69 respectively even after adjustment for referral bias 8 Published guidelines have also included a meta-analysis and confirmed a low level sensitivity33 of detection of disease Additionally the high rate of false positives as well as the inability to fully ascertain the extent of disease therefore limits the potential value of ECG stress testing
Even though exercise stress testing is supported by recent clinical guidelines the addition of SPECT myocardial perfusion imaging has independent and incremental diagnostic and prognostic value Improved diagnostic accuracy has also been noted with perfusion imaging and its ability to predict cardiac events in women is well established Furthermore recent data supports the cost-effectiveness of strategies that employ myocardial perfusion imaging in the assessment of women at risk for ICD
The current AHAACC recommendations fail to take into account that women often have limited ability to complete maximal exercise a problem that is likely due to their older age and more frequent co-morbidities as compared with men This functional impairment may lead to a lack of ischemia provocation andor indeterminate exercise testing results Maximal predicted heart rate oxygen consumption and more commonly metabolic equivalents METs are measures to estimate physical work capacity The Duke Activity Status Index DASI is a simple 12-item questionnaire that estimates peak oxygen consumption The Duke Activity Status Index DASI questionnaire may identify patients who are likely to perform inadequate exercise which amounts to nearly 40 of all women referred for exercise testing
The optimal strategy for the evaluation of women with suspected ischemic heart disease is unknown and quite controversial Several algorithms have been suggested for the evaluation of women with suspected CAD A recent consensus paper from the American Society of Nuclear Cardiology suggested a strategy that employed perfusion imaging but provided little evidence to support such a clinical strategy such as with a prospective clinical trial The focus of this investigation is to compare different strategies for the assessment of women at intermediate or high clinical risk for IHD and to do so on a prospective randomized basis This study is therefore focused on providing a high level of clinical evidence on which to base future recommendations and guidelines for the care of women with heart disease
Extrapolation of the published clinical trial data predominately obtained in men for women is controversial due to differences in epidemiology of heart disease in women Treatment is often sought later in life and is usually accompanied by more advanced disease and co-morbidities which therefore impact survival In addition women more frequently have an absence of clinical symptoms or an atypical presentation making the diagnosis of coronary artery disease CAD challenging Furthermore women may also have their first manifestation of CAD as sudden death or acute myocardial infarction Therefore there is a clear need for the early identification of IHD in women so that treatments may be employed prior to having an advanced state of disease and higher risk for unfavorable outcomes
The optimal non-invasive test for evaluation of IHD in women is unknown A number of different modalities have been employed including exercise ECG stress testing 2-dimensional stress echocardiography single photon emission computerized tomography SPECT myocardial perfusion imaging and electron beam tomography Additionally the cohort of women for whom testing is performed is also ill defined
The most recent AHAACC guidelines suggest that ECG stress testing should be the preferred approach Supportive data for this recommendation are controversial as many of the studies examining the diagnostic value of ECG stress testing were largely performed in small cohorts of women and are dated These trials indicate that the diagnostic accuracy of stress testing is only fair sensitivity32-89 specificity41-68 A recent meta-analysis in 3874 women demonstrated modest sensitivity and specificity 62 and 69 respectively even after adjustment for referral bias 8 Published guidelines have also included a meta-analysis and confirmed a low level sensitivity33 of detection of disease Additionally the high rate of false positives as well as the inability to fully ascertain the extent of disease therefore limits the potential value of ECG stress testing
Even though exercise stress testing is supported by recent clinical guidelines the addition of SPECT myocardial perfusion imaging has independent and incremental diagnostic and prognostic value Improved diagnostic accuracy has also been noted with perfusion imaging and its ability to predict cardiac events in women is well established Furthermore recent data supports the cost-effectiveness of strategies that employ myocardial perfusion imaging in the assessment of women at risk for ICD
The current AHAACC recommendations fail to take into account that women often have limited ability to complete maximal exercise a problem that is likely due to their older age and more frequent co-morbidities as compared with men This functional impairment may lead to a lack of ischemia provocation andor indeterminate exercise testing results Maximal predicted heart rate oxygen consumption and more commonly metabolic equivalents METs are measures to estimate physical work capacity The Duke Activity Status Index DASI is a simple 12-item questionnaire that estimates peak oxygen consumption The Duke Activity Status Index DASI questionnaire may identify patients who are likely to perform inadequate exercise which amounts to nearly 40 of all women referred for exercise testing
The optimal strategy for the evaluation of women with suspected ischemic heart disease is unknown and quite controversial Several algorithms have been suggested for the evaluation of women with suspected CAD A recent consensus paper from the American Society of Nuclear Cardiology suggested a strategy that employed perfusion imaging but provided little evidence to support such a clinical strategy such as with a prospective clinical trial The focus of this investigation is to compare different strategies for the assessment of women at intermediate or high clinical risk for IHD and to do so on a prospective randomized basis This study is therefore focused on providing a high level of clinical evidence on which to base future recommendations and guidelines for the care of women with heart disease
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 |
|---|---|---|---|
| The WOMEN study | None | None | None |