NCT07260552: RESPOND

Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease

Not yet recruiting Last updated 10 December 2025

What this trial tests

trial testing Polygenic risk score in Coronary Heart Disease in 200 participants. Not yet recruiting.

Timeline

1 February 2027

Primary endpoint
31 January 2030

1 September 2030

Quick facts

Lead sponsor	Medical College of Wisconsin
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 February 2027
Primary completion	31 January 2030
Estimated completion	1 September 2030

Drugs / interventions tested

• Polygenic risk score

Conditions studied

• Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

Medical College of Wisconsin

Who can join

Adults 40 to 69, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiometabolic diseases are major causes of morbidity and mortality in the state of Wisconsin and are expected to pose an increasing burden over the next few decades. A crucial initial step in preventing or delaying the onset of these diseases is to assess disease risk at the individual level. However, the accuracy of risk prediction of disease events based on conventional risk factors remains modest. Incorporating a polygenic risk score (PRS) into risk equations improves risk prediction but there is uncertainty about how best to integrate PRSs into primary care settings, given the lack of familiarity with PRSs among patients and providers. Probabilistic estimates for risks of cardiometabolic diseases may be misunderstood, and genetic risk assessment may not be trusted by those in low resource rural or inner-city settings. The potential for using PRSs to refine disease risk estimates has led to numerous studies to assess their clinical utility; however, the vast majority have been conducted in tertiary academic medical centers, raising concern that communities with diminished access to care could be left behind. The study team will investigate how the use of PRSs for such diseases influences health outcomes in rural and inner-city settings. The study team will leverage prior experience in conducting the MIGENES randomized clinical trial (RCT) of disclosing polygenic risk of CHD in a preventive cardiology setting of an academic center. In the proposed study, the investigators will conduct a pragmatic RCT to extend the investigation to 'real-world' settings of primary care clinics in a rural medical center and an urban Federally Qualified Health Center (FQHC). The investigators will engage a Community Advisory Board (CAB) through focus groups to gather feedback on implementing PRS-guided screening, related medical and lifestyle interventions, and public health strategies to reduce CHD risk. Feedback will inform provider education, targeted outreach to Wisconsin residents, and identification of barriers to adoption. The study team will also assess primary care physicians' and patients' familiarity with polygenic risk, their attitudes toward PRS testing, and intended actions based on results, comparing responses across rural and urban settings. The 10-yr risk of CHD will be estimated based on pooled cohort equations (PCE). Participants will view a video describing how cardiovascular risk was estimated and how lifestyle changes and drug therapy could reduce such risk and, in those randomized to receive PRS, the probabilistic nature of genetic risk. Patients will then see their PCP to review the 10-yr CHD risk estimate and engage in shared decision-making regarding statin therapy. Patient and clinician understanding of polygenic risk information will be assessed, as well as health-related and behavioral outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.