Grants and Contracts Details
Description
Cardiovascular disease (CVD), the leading cause of death in American women (nearly 400,000 annually), is predominantly due to ischemic heart disease (IHD) and heart failure (HF). Because women comprise > than 18% of our active duty military, Reserve and National Guard, and these numbers continue to increase as more women choose a military career, it is critical that women’s future CVD health needs be anticipated, rather than reacting to adverse CVD mortality and morbidity in future decades. Emerging data indicate that active duty military women are at increased CVD risk with unique and more prevalent stressors (depression, PTSD, cigarette smoking) associated with military service when compared to civilians. High atherosclerosis risk factor burden (hypertension, diabetes, dyslipidemia), and elevated obesity/overweight/low fitness levels are prevalent among military, dependent, VA, and private sector women, contributing to the rising CVD mortality rates in younger mid-life women observed in the US.
Among symptomatic (e.g. angina) women with abnormal stress testing undergoing coronary angiography, 40-65% have no obstructive coronary artery disease (CAD), termed “female-pattern IHD”. Considered “low risk”, they often receive no specific therapy and are dismissed from sub-specialty care. Yet evidence from the NHLBIWomen’s Ischemia Syndrome Evaluation (WISE), Veterans Administration Cardiovascular Assessment, Reporting and Tracking System (VA-CART), and National Cardiac Data Registry (NCDR) now documents that such subjects have higher than expected risk for major adverse cardiac events (MACE-death, MI, stroke, hospitalization for HF or angina. Pharmacologic probe trials document improvement in symptoms and intermediate ischemia markers with high intensity statin and ACE-I.
This background provides the rational for the first-ever large-scale, practical, outcome trial, to include female military; both active duty and retired, as well as veterans, dependents (wives and daughters) and the private sector
population of affected women in the State of Florida to test the efficacy of intensive medical therapy (IMT) in symptomatic women with abnormal stress testing and non-obstructive CAD compared to primary care guideline medical therapy (GMT). This trial builds on prior experience in obstructive CAD (VA-bypass, COURAGE, etc.) and is now feasible and economical with a pragmatic trial design; combining the infrastructure of a PCOR.net Clinical Data Research Consortium (electronic health records (EHR) data capability); a large, accessible female active duty and veteran population; and novel digital technology.
The study will break new ground in several respects. In addition to including a sample size large enough to assess, for the first time, whether a practical medical treatment strategy considered safe and effective for obstructive CAD influences clinical outcomes in a non-obstructive CAD population of military/veteran women. We will also evaluate symptomatic quality of life and cost effectiveness in this cohort. This information will advance our understanding of therapy for “female-pattern” IHD, to inform current guidelines for treatment which currently recommend only reassurance and symptom management. This trial has public health implications to provide the evidence-base to inform guidelines and decrease a major source of mortality, morbidity and health-care costs for women.
Status | Finished |
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Effective start/end date | 11/26/18 → 9/14/23 |
Funding
- University of Florida: $14,881.00
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