CERSI Collaborators: Matthew Burg, PhD (Yale), Kristie Harris, PhD (Yale), Molly Jeffery, PhD (Mayo Clinic), Carolyn Mazure, PhD (Yale), Carlos Mena, MD (Yale), Steven Pfau, MD (Yale), Joseph Ross, MD, MHS (Yale), Samit Shah, MD, PhD (Yale) (PI), Kim Smolderen, PhD, MSc (Yale), Erica Spatz, MD, MHS (Yale)
FDA Collaborators: David Reasner, PhD, Susan Bersoff-Matcha, MD, FKaveeta Vasisht, MD, PharmD
Project Start Date: March 30, 2022
Regulatory Science Challenge
Ischemic heart disease (IHD) is a leading cause of illness and death in women. The health outcomes vary greatly across women who have IHD because the way the disease presents itself is different than men, where most of the outcomes have been studied. This is partly because women present with unique symptoms that are not fully consistent with traditional models of IHD, and women are less likely than men to have obstructive atherosclerotic coronary artery disease (CAD), which is the most widely recognized form of IHD.
Instead, women often suffer from myocardial ischemia with no obstructive coronary arteries (INOCA), meaning that there are no visible blockages in their arteries. Although recognition of and research on INOCA has increased in recent years, there is no specific way to measure the impact on the persons health. This project will develop measures to better assess INOCA, thereby improving evaluation, diagnosis, and treatment of women with the disease.
Project Description and Goals
The goal of this project is to develop and validate a patient reported outcome measure (PROM) that can assess the overall health status of women with INOCA. The PROM will be in the form of a self-report questionnaire and will measure patients’ frequency/stability of symptoms, physical limitation, perception of illness, psychological toll, and functional limitation. To achieve this goal, we will conduct structured interviews with women with INOCA to extract recurrent themes. These themes will contribute to initial development of the PROM, which will be evaluated and further refined. Finally, we will evaluate validity of the PROM for use with specific types of INOCA (i.e., coronary microvascular dysfunction, coronary vasospasm, or other disorders of coronary physiology). The resulting PROM may be used by healthcare providers and their patients to improve the assessment of symptoms and functional impact of therapies for women with INOCA.