Ariane deGennaro, Staff Illustrator

In collaboration with Women’s Health Research at Yale, University scientists are leading a pilot clinical study on improving heart disease diagnosis for women — in hopes of highlighting the effectiveness of additional diagnostic procedures aside from the existing standard of care. 

The study is a branch of a larger Women’s Health Research project to examine gender disparities in cardiovascular health, made possible by the 2021 Wendy U. and Thomas C. Naratil Pioneer Award — which will give principal investigator Samit Shah up to $50,000 in grant money. Shah first received funds on July 1. Currently, the team is enrolling 100 female research participants whose experiences with cardiovascular treatment at the Yale New Haven Health System will be documented and examined over the next two years. 

“When we look at all people, we should cater what we’re doing based on the person,” said Shah, who is also an interventional cardiologist and an assistant professor of medicine. “Cardiologists and patients should always ask what more can we do.” 

According to Shah, the basis for his study lies in a need to adopt a more thorough means of assessing cardiovascular problems. Fifty percent of women who have symptoms of heart disease do not show a blockage after cardiac catheterization — the current standard of care which involves inserting a long thin tube through the blood vessels to the heart and an angiogram. As a result, they are sent home without a diagnosis, only to find themselves in the same emergency room suffering from the same symptoms a few months later, Shah said. 

The same protocol, however, is more effective in generating a proper diagnosis for men, who are more likely to show blockages due to higher levels of testosterone.

We can attribute some of these disparities in diagnosis to the biological differences between men and women,” said Erica Spatz, associate professor of cardiology and epidemiology and a collaborator on the study. 

Having conducted a past study that found that most women have heart attacks that are not classified as the same types as men have, she cited hormonal changes as a key factor. Unlike testosterone, estrogen protects against plaque formation in blood vessels, making blockages less detectable through catheterization despite women showing the same heart disease symptoms. Moreover, she explained that estrogen delays the onset of heart disease in women by about 10 years, a process that according to Shah, stops once women reach menopause. 

The problem is that medical workers are devoting too much attention to finding these blockages, which also need to be identified, Shah explained. One concern is that researchers lose sight of other factors. Additionally, catheterization is an invasive procedure, detrimental to a patient’s physiological health if performed frequently.

In his study, he plans to conduct additional procedures and testing following catheterization to ensure that women receive a proper, timely diagnosis. 

“We try to be totally comprehensive . . . we measure the blood flow; we measure the resistance in the small blood vessels that we can’t see when we take pictures; and then we test the blood vessels for how well they open and close,” Shah said, emphasizing that patients deserve answers and should be made aware of why and how exactly they are developing adverse symptoms. 

Aside from attempting to diagnose patients and provide them with proper medication, the study also encompasses a qualitative aspect, wherein the researchers conduct structured interviews to assess patients’ symptoms, emotions, medication and lifestyle changes throughout the two years of clinical study and testing. 

The cohort of research participants participating in the interviews, obtained through purposive sampling and who were all recommended for cardiac angiography, will be divided into two groups: one that receives the existing standard of care and another that also undergoes additional procedures supplementing the catheterization. 

Yale medical student Leslie Tseng MED ’23, who received a scholarship to work on this project full-time, explained that the interviews delve beyond yes and no questions to better capture the experiences of the participants before and after the procedures. 

According to Tseng, the answers can be used to engineer a better quality of life for patients, as well as understand how patients will individually benefit from more accurate diagnoses — be it for self-reassurance, access to support and therapy programs or other reasons. To ensure that these perspectives are coming from a diverse group, “we are also doing chart review to look at everyone’s demographic factors, such as ethnicity and zip code,” Tseng added. 

The researchers aim to incorporate qualitative patient perspectives in their explanation to justify why additional medical procedures should be made the standard of care in medical institutions throughout the country. 

Tseng also spoke to some of the challenges currently facing the project: testing modules are new and there isn’t a large existing cohort currently undergoing these tests. Shah is hopeful that with time, the team will be able to recruit a larger number of participants and expand the pilot study to collaborate with new partner institutions.

The study is being performed locally at Yale, currently the only enrolling center. 

Correction, Oct. 7 The article has been updated to reflect that the study is being performed at Yale alone, not 10 different countries. 

BRIAN ZHANG
Brian Zhang is a first year in Davenport College.