Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in levels of myocardial injury biomarkers (such as TNI and CK‐MB) between low temperature contrast group and room temperature contrast group. Based on previous study, the incidence rate of PCI‐related myocardial injury is 28.7% in UAP patients undergoing PCI. And in our study the expected incidence rate of PCI‐related myocardial injury is up to 14.3% in UAP patients undergoing PCI after treatment with low temperature contrast. Moreover, the investigators estimated 10% loss follow‐up of these patients in each arm. As a result, a total of 440 UAP patients were required, and with 220 patients per group as a ratio of 1:1 randomization.