Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000554
Status:
COMPLETED
Last Update Posted:
2014-04-04
First Post:
1999-10-27
Brief Title:
Womens Ischemia Syndrome Evaluation WISE
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-04
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:
To evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women Innovative approaches proposed include physiologic or functional measurements such as impaired metabolism perfusion or endothelial function as well as assessment of epicardial coronary arteries by angiography Other objectives include developing safe accurate and cost effective diagnostic approaches for evaluating women with suspected ischemic heart disease and determining the frequency of myocardial ischemia in the absence of significant epicardial coronary stenosis as well as the frequency of non-ischemic or non-cardiac chest pain A key aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in the absence of obstructive coronary disease
Detailed Description:
BACKGROUND
Cardiovascular disease exacts a heavy burden on the health of women Ischemic heart disease claims the lives of nearly 250000 women in the United States each year Recognition of ischemic heart disease in women is a major challenge to the primary care physician Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain or events such as a myocardial infarction which are evaluated by a physician who will confirm the diagnosis with objective tests Unfortunately both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women Chest pain syndromes suspicious for myocardial ischemia are common in women Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physicians decision to further evaluate women at risk With precision in diagnosis efforts to optimize therapies are hampered
The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology The utility of this approach is well established However although the presence of atherosclerosis is sufficient to cause myocardial ischemia whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis is not known and may be important for women
Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis Cycling hormones may further influence these complex interactions Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or for example endothelial dysfunction which places the patient at risk for untoward coronary events
The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart Lung and Blood Advisory Council The Request for Proposals was released in April 1994
DESIGN NARRATIVE
The Womens Ischemia Syndrome Evaluation WISE was a four center study designed to evaluate ischemic heart disease and its pathophysiology in women WISE testing focused on three areas 1 optimizing symptom evaluation and diagnostic testing for ischemic heart disease 2 exploring mechanisms for symptoms and evidence of myocardial ischemia in the absence of epicardial coronary artery disease 3 evaluating the influence of reproductive hormones on symptoms and diagnostic test response The WISE core data base included demographic and clinical data symptom and psychosocial variables coronary angiography and ventriculography data blood lipoproteinhomocysteinelipid peroxidationgenetichormone phytoestrogen analysis brachial artery reactivity testing and restingambulatory electrocardiographic ECG monitoring Site specific complementary methods included physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism ventriculography endothelial vascular function and coronary angiography Women were followed for at least one year to assess clinical events and symptom status In the Phase I 1996-7 a pilot phase 256 women were studied Phase II has completed enrolling 1008 women in the study The WISE study defined contemporary and comprehensive state-of-the-art diagnostic testing to evaluate women with suspected ischemic heart disease and explore sex specific ischemic heart disease pathophysiology
The study has been renewed through April 2005 to extend patient follow-up for a minimum of five years Dr Kelsey U01HL64829 of the Data Coordinating Center at the University of Pittsburgh will continue the follow-up develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables assess cost effectiveness of the WISE testing techniques and continue data analyses Dr Reis U01HL64914 will study the immunologic basis of coronary disease in women focusing on the role of inflammation and cytokine production He will measure several cytokines and cytokine-related proteins and genotypes in approximately 900 stored samples from WISE participants Dr Pepine U01HL64924 will study the renin angiotensin system in coronary microvascular dysfunction focusing on whether polymorphisms of the renin-angiotensinkallikrein-kinin systems and beta-adrenergic receptors polymorphisms are associated with abnormal coronary microvascular function determined by coronary flow reserve measurements
Cardiovascular disease exacts a heavy burden on the health of women Ischemic heart disease claims the lives of nearly 250000 women in the United States each year Recognition of ischemic heart disease in women is a major challenge to the primary care physician Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain or events such as a myocardial infarction which are evaluated by a physician who will confirm the diagnosis with objective tests Unfortunately both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women Chest pain syndromes suspicious for myocardial ischemia are common in women Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physicians decision to further evaluate women at risk With precision in diagnosis efforts to optimize therapies are hampered
The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology The utility of this approach is well established However although the presence of atherosclerosis is sufficient to cause myocardial ischemia whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis is not known and may be important for women
Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis Cycling hormones may further influence these complex interactions Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or for example endothelial dysfunction which places the patient at risk for untoward coronary events
The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart Lung and Blood Advisory Council The Request for Proposals was released in April 1994
DESIGN NARRATIVE
The Womens Ischemia Syndrome Evaluation WISE was a four center study designed to evaluate ischemic heart disease and its pathophysiology in women WISE testing focused on three areas 1 optimizing symptom evaluation and diagnostic testing for ischemic heart disease 2 exploring mechanisms for symptoms and evidence of myocardial ischemia in the absence of epicardial coronary artery disease 3 evaluating the influence of reproductive hormones on symptoms and diagnostic test response The WISE core data base included demographic and clinical data symptom and psychosocial variables coronary angiography and ventriculography data blood lipoproteinhomocysteinelipid peroxidationgenetichormone phytoestrogen analysis brachial artery reactivity testing and restingambulatory electrocardiographic ECG monitoring Site specific complementary methods included physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism ventriculography endothelial vascular function and coronary angiography Women were followed for at least one year to assess clinical events and symptom status In the Phase I 1996-7 a pilot phase 256 women were studied Phase II has completed enrolling 1008 women in the study The WISE study defined contemporary and comprehensive state-of-the-art diagnostic testing to evaluate women with suspected ischemic heart disease and explore sex specific ischemic heart disease pathophysiology
The study has been renewed through April 2005 to extend patient follow-up for a minimum of five years Dr Kelsey U01HL64829 of the Data Coordinating Center at the University of Pittsburgh will continue the follow-up develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables assess cost effectiveness of the WISE testing techniques and continue data analyses Dr Reis U01HL64914 will study the immunologic basis of coronary disease in women focusing on the role of inflammation and cytokine production He will measure several cytokines and cytokine-related proteins and genotypes in approximately 900 stored samples from WISE participants Dr Pepine U01HL64924 will study the renin angiotensin system in coronary microvascular dysfunction focusing on whether polymorphisms of the renin-angiotensinkallikrein-kinin systems and beta-adrenergic receptors polymorphisms are associated with abnormal coronary microvascular function determined by coronary flow reserve measurements
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL064829 | NIH | None | httpsreporternihgovquickSearchU01HL064829 |