Identifying high yield sources of patients with coronary artery disease for clinical trials: lessons from the Asymptomatic Cardiac Ischemia Pilot (ACIP) experience. The ACIP Study Group.

BACKGROUND AND HYPOTHESIS

Successful recruitment strategies for ischemic heart disease (IHD) clinical trials must identify high yield sources and efficient methods for selecting patients likely to have coronary artery disease (CAD) and ischemia, but such information is lacking.

METHODS

Data from the recently completed Asymptomatic Cardiac Ischemia Pilot (ACIP) Trial were used as a model contemporary CAD/IHD trial to determine the relative patient yields, within a specific time frame, for various recruitment sources.

RESULTS

Over 15 months, a total of 88,881 patient records was screened at 10 sites. The highest yield source was found by screening records of patients directly referred by a physician for possible study entry. This source accounted for 595 of 814 or 73% of potential patients and for 30% of patients eventually randomized. The largest volume of potential patients was observed from coronary angiographic laboratory record screening, and this source accounted for 39% (n = 7.542) of potential patients and for 24% of those randomized. The exercise electrocardiography (ECG) laboratory patient records yielded only 16% (5,340/33,784) of potential patients and 35% of patients randomized, but this source required considerably more time and resources for screening.

CONCLUSION

Considering that time and resources for screening are fixed by budget in any trial, there is a need to balance high volume-moderate yield sources with low volume-high yield sources in order to optimize recruitment in future larger scale trials, and these data provide information and direction to focus such screening efforts.