Patient Perspectives in Cardiovascular Research: A Qualitative Study of Barriers, Trust, and Strategies for Inclusive Clinical Trials

BACKGROUND: Women, Black, and Hispanic patients bear a disproportionate burden of cardiovascular disease yet remain underrepresented in clinical trials. Understanding patient perspectives is essential to developing inclusive recruitment strategies in cardiovascular research. METHODS: The RECHARGE trial (Revascularization Choices Among Underrepresented Groups Evaluation) is an ongoing comparative effectiveness study comparing percutaneous coronary intervention and coronary artery bypass grafting among women, Black, and Hispanic patients. To inform recruitment strategies, we conducted a qualitative study using in-person and virtual focus groups and semistructured interviews. Participants were US adults who identified as Black or Hispanic and had a history of percutaneous coronary intervention, coronary artery bypass grafting, or advanced cardiovascular disease. Interviews were guided by the Social-Ecological Model and analyzed using directed content analysis with a constant comparative approach. RESULTS: The sample included 42 participants (35 women, 7 men); 29 identified as Hispanic and 13 as Black. Barriers and facilitators to trial participation spanned multiple levels of the Social-Ecological Model. At the individual and interpersonal levels, barriers included complex study materials, excessive medical jargon, and mistrust of randomization, with concerns about being assigned a less effective treatment. At community and societal levels, participants cited limited recruitment outreach, lack of culturally and linguistically appropriate materials, and mistrust stemming from historical research injustices. Facilitators included trust in healthcare providers, reassurance regarding treatment appropriateness, and involvement of family or support systems. At the community and societal levels, accessible, visual, and multilingual materials were highlighted to support understanding. Participants emphasized the value of plain language, visual, and multilingual materials, adequate time for shared decision-making, and transparent communication about study goals. CONCLUSIONS: Increasing representation of underrepresented populations in cardiovascular trials requires transparent, accessible communication and trust-centered recruitment strategies. Leveraging trusted healthcare providers and community-based outreach is critical to advancing equity in cardiovascular research. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT06399705 and NCT06399692.