The triad of cohort discovery, enrollment, and enrollment monitoring is critical to running efficient and excellent clinical trials. Including the medical device used to enroll patients is central to the device-based solutions developed by Tufts Medical Center.

The IMMEDIATE Trial used an innovative ECG-based enrollment monitoring system, developed by Tufts Medical Center, to aid decision making and track site performance. Enrollment for the Trial was 52% of all eligible participants, an impressive figure for an emergency medicine trial.

Paramedic identification of potential study participants was aided by electrocardiograph-based acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI), and thrombolytic predictive instrument (TPI) decision support. These predictive instruments provided a probability score of whether the patient had ACS or not, based on age, gender and ECG readout. Patients that had an ACI-TIPI score of 75% or greater, and/or the detection of STEMI by the TPI were eligible for enrollment.

The IMMEDIATE-2 Trial will use the same ECG-based system as was used in the IMMEDIATE Trial, in both the EMS and ED settings. In addition to enrollment and enrollment monitoring, this system will be crucial in the cohort discovery and site selection process. Using stored ECG records, accessed through the hospital HeartStation and retrospectively applying the ACI-TIPI algorithm, we can obtain more accurate estimates of the number of eligible patients.

Figure 1.0 IMMEDIATE Trial ECG-based Enrollment Monitoring

Figure 2.0 ECG-based Cohort Discovery for IMMEDIATE-2 Trial: Example at One Hospital (Vanderbilt University)

Figure 3.0 IMMEDIATE-2 Trial Clinical Data Flow