1 The WISE Study: The WISE Study: The NHLBI-Sponsored Women’s The NHLBI-Sponsored Women’s Ischemia Syndrome Evaluation Ischemia Syndrome Evaluation Methods and Findings Methods and Findings B. Delia Johnson, Ph.D. Research Associate, EDC Epidemiology Seminar Series, October 6, 2005 Graduate School of Public Health, University of Pittsburgh
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1 The WISE Study: The NHLBI-Sponsored Women’s Ischemia Syndrome Evaluation Methods and Findings B. Delia Johnson, Ph.D. Research Associate, EDC Epidemiology.
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The WISE Study:The WISE Study:The NHLBI-Sponsored Women’s The NHLBI-Sponsored Women’s Ischemia Syndrome EvaluationIschemia Syndrome Evaluation
Methods and FindingsMethods and Findings
B. Delia Johnson, Ph.D.Research Associate, EDC
Epidemiology Seminar Series, October 6, 2005
Graduate School of Public Health, University of Pittsburgh
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• Background
• WISE Overview
• Key Findings
• Implications / Impact
OutlineOutline
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BackgroundBackground
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Women and Heart Disease - 1Women and Heart Disease - 1
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Women and Heart Disease - 2Women and Heart Disease - 2
Cardiovascular Disease Mortality Trends for Males and Females
United States: 1979-2002
380
400
420
440
460
480
500
520
79 81 83 85 87 89 91 93 95 97 99 01
Years
Dea
ths
in T
ho
usa
nd
s
Males Females
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Women and Heart Disease - 3Women and Heart Disease - 3
Prevalence of Obstructive CAD at Angiography in Women
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• Insufficient amount of oxygen reaching the heart muscle;
• Often exercise or anxiety induced;
• Reversible dysfunction or prolonged & severe;
• Chest pain or “silent;”
• Transient ECG abnormalities;
• Over time, the affected heart tissue may die;
• Many possible causes:– Obstructed coronary arteries (CAD)
– Endothelial dysfunction
– coronary vasoconstriction
– Microvascular insufficiency.
What is Myocardial Ischemia?What is Myocardial Ischemia?
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WISE OverviewWISE Overview
The Women’s Ischemia Syndrome Evaluation
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1. Develop accurate diagnostic approaches for CAD 1. Develop accurate diagnostic approaches for CAD detection in women.detection in women.
2. Determine the frequency, pathophysiology, and 2. Determine the frequency, pathophysiology, and significance of myocardial ischemia in the absence significance of myocardial ischemia in the absence of significant CAD in women.of significant CAD in women.
3. Evaluate the influence of hormones on 3. Evaluate the influence of hormones on pathophysiology and diagnostic test response. pathophysiology and diagnostic test response.
WISE GoalsWISE Goals
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• A four-center NHLBI-sponsored studyA four-center NHLBI-sponsored study
• 936 women undergoing clinically 936 women undergoing clinically ordered coronary angiographyordered coronary angiography
• Observational studyObservational study
In BriefIn Brief
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• A type of study in which individuals are observed or certain outcomes measured;
• No attempt to affect the outcome (e.g. no treatment);
• Determine incremental prognostic value of novel WISE tests
• Determine prognostic value of female reproductive variables
• Determine cost effectiveness of WISE tests
• Genetics
• Inflammatory markers
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Sept.
1996
Oct.
2005
20008557 women screened22% eligible; 50% of
these enrolled (N=936)
WISE Extension:
Annual Follow-Ups
FemHRT
QWISE
IVUS WTH EWISE
WISE Ancillary Studies
YWISE
ARIC
WISE Timeline - 2WISE Timeline - 2
Sildenafil
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Population Characteristics - 1Population Characteristics - 1
Age – years [mean + SD (range)] 58 + 12 (21-86)
Postmenopausal (%) 76
Ethnic minority (%) 19
Chest pain or other symptoms (%) 94
CAD (50%+ stenosis) (%) 39
Prior MI or revascularization (%) 29
BMI [mean + SD (range)] 29.7+6.6 (14.0-57.2)
Obese (BMI > 30) (%) 41
Metabolic syndrome (%) 47
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Population Characteristics - 2Population Characteristics - 2
Rx: Lipid Lowering (%) 29
Rx: Anti-Hypertensive (%) 48
Rx: Psychoactive (%) 30
Hx smoking (%) 53
Current smoking (%) 20
Diabetes (%) 25
Hx hypertension (%) 59
Hx dyslipidemia (%) 55
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Reasons for CatheterizationReasons for Catheterization
Chest pain 92%
Shortness of breath 58%
Abnormal stress test 45%
Syncope 10%
Preoperative clearance 4%
Unknown 1%
Other (e.g. fatigue, dizziness, nausea, EKG changes) 12%
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Key FindingsKey Findings
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1.1. Develop accurate diagnostic approaches Develop accurate diagnostic approaches for CAD detection in women.for CAD detection in women.
• Is classic angina diagnostic for CAD in women?Is classic angina diagnostic for CAD in women?
2. Determine the frequency, pathophysiology, 2. Determine the frequency, pathophysiology, and significance of myocardial ischemia in and significance of myocardial ischemia in the absence of significant CAD in women.the absence of significant CAD in women.
3. Evaluate the influence of hormones on 3. Evaluate the influence of hormones on pathophysiology and diagnostic test pathophysiology and diagnostic test response.response.
WISE GoalsWISE Goals
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• 481 WISE women481 WISE women
• Symptomatic in prior yearSymptomatic in prior year
• No prior MI or procedureNo prior MI or procedure
Probability* CAD Probability* CAD by Anginal Classification and Age in Womenby Anginal Classification and Age in Women
Age 35-45 Age 45-55
Age 55-65 Age 65-75
*Data from Diamond (1980 J Clin Invest. 65:1210-21)
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Probability vs. WISE Prevalence* of CAD by Anginal Probability vs. WISE Prevalence* of CAD by Anginal Classification and AgeClassification and Age
Age 45-55, n=141Age 35-45, n=57
Age 55-65, n=137 Age 65-75, n=114
* Adjusted for diabetes, dyslipidemia, smoking, SBP
Source: Johnson et al. Chapter 10 in Shaw & Redberg (Eds.) Contemporary Cardiology: Coronary Disease in Women. Humana Press 2004.
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• Overall, typical angina is not a good diagnostic Overall, typical angina is not a good diagnostic indicator of CAD in women;indicator of CAD in women;
• After age 55, classic angina classification is After age 55, classic angina classification is moderately predictive of CAD.moderately predictive of CAD.
Angina - ConclusionsAngina - Conclusions
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1.1. Develop accurate diagnostic approaches Develop accurate diagnostic approaches for CAD detection in women.for CAD detection in women.
2. 2. Determine the frequency, pathophysiology, Determine the frequency, pathophysiology, and significance of myocardial ischemia in and significance of myocardial ischemia in the absence of significant CAD in womenthe absence of significant CAD in women..
– Is metabolic dysfunction in the heart predictive Is metabolic dysfunction in the heart predictive of cardiovascular outcomes?of cardiovascular outcomes?
3. Evaluate the influence of hormones on 3. Evaluate the influence of hormones on pathophysiology and diagnostic test pathophysiology and diagnostic test response.response.
• Abnormal MRS spectroscopy results Abnormal MRS spectroscopy results are found in about 20% of women are found in about 20% of women with chest pain but no CAD;with chest pain but no CAD;
• This abnormality is predictive of This abnormality is predictive of cardiovascular events – ischemia-cardiovascular events – ischemia-related hospitalization.related hospitalization.
1. Develop accurate diagnostic approaches for 1. Develop accurate diagnostic approaches for CAD detection in women.CAD detection in women.
2. Determine the frequency, pathophysiology, 2. Determine the frequency, pathophysiology, and significance of myocardial ischemia in and significance of myocardial ischemia in the absence of significant CAD in women.the absence of significant CAD in women.
3. 3. Evaluate the influence of hormones on Evaluate the influence of hormones on pathophysiology and diagnostic test pathophysiology and diagnostic test response.response.
– Is there a relationship between endogenous Is there a relationship between endogenous reproductive hormones and CAD?reproductive hormones and CAD?
• Premenopausal women with obstructive Premenopausal women with obstructive CAD are highly likely to have hypothalamic CAD are highly likely to have hypothalamic hypoestrogenemia;hypoestrogenemia;
• This condition is related to anxiety (as This condition is related to anxiety (as suggested by anti-anxiety medications) suggested by anti-anxiety medications) and diabetes. and diabetes.
• 118 abstracts at scientific meetings:– American Heart Association– American College of Cardiology– Society for Cardiovascular Magnetic Resonance– International Congress on Coronary Artery Disease– North American Menopause Society– Inter-American Society of Hypertension– American Psychosomatic Society– AHA Forum on Quality of Care and Outcomes Research in
Cardiovascular Disease and Stroke– European Society of Cardiology– International Society for Magnetic Resonance in Medicine– Society for Cardiac Angiography and Interventions– AHA Council on Cardiovascular Disease Epidemiology– International Symposium on Women’s Health and Menopause– American Society for Clinical Pharmacology and Therapeutics– Heart Failure Society of America– First International Conference on Women, Heart Disease and Stroke– World Congress of Cardiology