Development and Validation of Risk Prediction Model for New-Onset Diabetes After Percutaneous Coronary Intervention (NODAP): A Study Protocol for a Retrospective, Multicenter Analysis

Background: Type 2 Diabetes mellitus (T2DM) is a major risk factor for cardiovascular diseases and increase mortality. Clinical outcomes of patients after percutaneous coronary intervention (PCI) were worse in T2DM patients than those without T2DM. New-onset diabetes after PCI (NODAP) is often observed during long-term follow-up and this further aggravates cardiovascular diseases. Several studies had focused on patients after PCI with known T2DM. Previous studies showed that impaired glucose tolerance and aging are risk factors that promote NODAP. Considering the unique characteristics of patients after PCI, we will further study relevant risk factors. We sought to investigate the potential predictors of acute coronary syndrome patients with NODAP by a multicenter retrospective cohort study. Methods: This is a multicenter retrospective cohort study including patients after PCI. Clinical medical records of these patients were collected from four hospitals in different areas in China, from 2010 to 2021. Patients' demographic information, medical history, diagnostic testing, PCI-related information, medication situation will be summarized using descriptive statistics, and correlation analysis was performed on the development of new-onset diabetes. Variation will be described and evaluated using χ(2) test or Kreskas-Wallis test. The prediction model will be verified by a validation set. Discussion: A novel diabetes prediction model for patients after PCI is established, and this study can achieve advanced intervention for the occurrence of NODAP. Owing to its retrospective nature, this study has some limitations, but it will be further studied through supplement data collection or prospective study. The study has been registered for clinical trials by the Chinese Clinical Trial Registry (ChiCTR2100047241).