INCIDENTAL CLINICAL FINDINGS THROUGH RESEARCH PARTICIPATION IN THE NORTH TEXAS HEALTHY HEART STUDY

Purpose: There is little literature that explores the benefits and implications of the use of Computed Tomography (CT) scans for research purposes. The purpose of this study was to examine incidental findings resulting from CT scans by participating in a behavioral research study that investigated disparities in cardiovascular health outcomes. Methods: A total of 571 asymptomatic adult participants were recruited in the North Texas Healthy Heart Study. All participants completed a one-hour in person interview, body measurements, lab analysis and a 16-slice CT scan of the heart and abdomen used to assess for Coronary Calcium Score and Visceral Adipose Tissue. Radiology reports were reviewed and all findings were categorized as having "clinical" or "unknown" significance. Three years of follow-up documentation were reviewed for status of radiology report findings. Study procedures where IRB approved by the UNTHSC (IRB # 2006-006, 2007-058). Results: There were at least four cases in the present study that resulted in a significant clinical intervention out of the 510 participants who completed CT scans, equivalent to one life saved per 127.5 scans. Of the 510 participants who completed a CT scan, 169 participants had a total of 246 clinically significant findings and 310 participants had a total of 467 findings of unknown significance. 145 participants had a CAC score of greater than 0, and of those, 19 participants had a CAC of greater than 500. Conclusions: The use of CT scans to test for coronary calcium is not clinically recommended in asymptomatic persons, and can result in unnecessary exposure to radiation. However, CT scans used during the course of study procedures can result in clinically significant findings that may otherwise have not been identified and constitutes an often unspoken benefit to participants. The consent process in research settings plays an important role in conveying the risks and benefits of clinical tests provided during the course of study procedures, particularly in addressing the difference between participating in research and testing provided for clinical care purposes.