HeartForce has successfully completed the data collection of 1500 patients, suspected of having coronary artery disease (CAD), in the clinical trial in Uzbekistan. Seismocardiography and gyrocardiography, for a non-invasive CAD diagnosis, were compared to coronary artery calcium computed tomography (CAC-CT), coronary computed tomography (CCTA), and invasive coronary angiography (ICA).
The datasets were collected between the months of July 2021 to November 2021 in Tashkent and Qarshi.
Among the 1500 patients, 1094 patients were referred to ICA, 365 were referred to CAC-CT and 39 patients underwent a CCTA test. More than 77% of patients recruited in this study had at least one occlusion in one of the coronary arteries. Among the 23% without any occlusions, more than 75% were symptomatic (i.e., chest pain or shortness of breath).
To develop a universal screening model for the detection of coronary artery disease, it was critical to perform the data analysis on a balanced dataset, which consists of similar numbers of patients with and without coronary occlusions. In view of the foregoing, HeartForce decided to add 300 age-matched, healthy individuals to offset the high number of unhealthy individuals. At present, HeartForce has already successfully recruited 102 healthy individuals without any prior heart disease. The aforesaid data collection is being conducted in Tashkent between the months of November 2021 to January 2022.
HeartForce is confident that this study will be completed by January 2022 – at which point a comprehensive CAD report will be released. Included in the report will be an in-depth, evidence-based analysis for the determination of the overall CAD accuracy, sensitivity, and specificity of our screening technology in comparison to CAC, CCTA, and ICA, as well as the vibration signal comparisons, before and after stent procedures.