Valley Health System participates in 1st cardiac surgery clinical trial for women

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Valley Health System said it recently began participating in the ROMA: WOMEN clinical trial, the first cardiovascular surgery clinical trial in women. Two patients were enrolled in the program, which is sponsored by Weill Medical College of Cornell University and the Starr Foundation.

The trial is designed to determine which bypass graft type is more effective for women with coronary artery disease who are undergoing a coronary artery bypass grafting procedure. In total, more than 2,000 patients are expected to be enrolled and will be followed by the sponsor’s research team for up to 12 years from the time of inclusion in the trial.

About coronary artery disease

Coronary artery disease is a narrowing or blockage of the arteries that deliver blood and oxygen to the heart muscle. CAD is the most common type of heart disease, which is the leading cause of death among women, according to the Centers for Disease Control and Prevention. Coronary Artery Bypass Grafting provides a very effective treatment, with significant survival advantages over any other form of treatment of multivessel coronary artery disease. During the procedure, a cardiac surgeon will reroute blood flow by bypassing blocked arteries using bypass grafts, or healthy blood vessels harvested from the chest, arms or legs.

The ROMA: WOMEN study will help researchers determine whether the use of multiple arterial grafts — the use of two or more arterial grafts — is safer and more effective than single arterial grafts — the use of one arterial graft — for women who are undergoing a CABG procedure.

Women are historically underrepresented in clinical trials, and research has shown that they are less likely to receive optimal treatment for their CAD. Also, women are more likely to have poorer outcomes than men with the same condition.

The ROMA: WOMEN study provides an opportunity to focus exclusively on enrolling women patients and supporting an improved understanding about what surgical strategies are best for these patients.

“I am thrilled to report Valley’s involvement in this revolutionary cardiac surgery clinical trial. Traditionally, women have been underrepresented in clinical trials. The ROMA trial challenges this stereotype, calling for more research relating to women’s cardiovascular health, specifically as it relates to guideline-directed surgical care,” Dr. Juan Grau, director of cardiothoracic surgery for the Valley Hospital, and principal investigator at Valley Health System, said.

“Valley’s participation in the ROMA trial aligns with the organization’s vision to foster diversity, equity & inclusion in research and clinical trials for underrepresented patient populations, including racial and ethnic minority groups,” Julia Karcher, senior vice president of Valley Health System and Valley Medical Group, said. “I am proud of Valley’s participation and the steps taken to implement a change within the cardiac surgery research space.”

To participate, women must be 18 years old or older and have a diagnosis of significant disease of the left main coronary artery or disease involving two or more coronary artery branches with a recommendation for an isolated coronary artery bypass grafting procedure as a treatment. Additionally, the patient may not have had prior cardiac surgery.

Learn more about this clinical trial and the eligibility criteria by visiting For more information about the trial, or to see if you are eligible, please call 201-634-5792.