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Not Yet Recruiting NCT07623213

AI-Guided Intensified Follow-up After Surgery for Acute Type A Aortic Dissection

Conditions: Acute Type A Aortic Dissection, Stanford Type A Aortic Dissection, Postoperative Aortic Dissection Follow-up

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1314
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Summary

This multicenter, prospective, randomized controlled trial will evaluate whether an artificial intelligence (AI) multimodal prediction model-guided intensified follow-up strategy improves 1-year outcomes after surgery for acute Stanford type A aortic dissection. Eligible adult patients who have undergone open surgical repair or open plus endovascular/hybrid repair and are clinically stable to enter the postoperative follow-up phase will be randomized 1:1 to usual postoperative follow-up or AI-guided intensified follow-up. The AI-guided arm will receive usual follow-up plus an AI-generated risk stratification report for 1-year mortality and adverse aortic remodeling. Higher-risk patients may receive more frequent follow-up, prioritized CTA review, multidisciplinary assessment, and targeted management reminders. The primary outcome is all-cause mortality through postoperative day 365. Key secondary outcomes include aortic reintervention, adverse aortic remodeling, and ICU readmission within 1 year.

Eligibility Criteria

Inclusion Criteria: * 1\. Age 18 years or older. 2. Acute Stanford type A aortic dissection confirmed by CTA, intraoperative findings, or medical records. 3\. Underwent open surgical repair or open repair combined with endovascular/hybrid repair. 4\. Postoperative condition is stable and the patient is planned for discharge or has entered early post-discharge follow-up. 5\. Core baseline data required for AI model operation are available, including at least one eligible preoperative or postoperative CTA imaging dataset. 6\. Able to complete telephone, outpatient, or inpatient follow-up and willing to provide written informed consent. Exclusion Criteria: * 1\. Predominantly chronic type A dissection, traumatic dissection, or iatrogenic dissection, if the investigator judges the patient unsuitable for this follow-up strategy study. 2\. Did not undergo surgical repair, received only palliative treatment, or did not meet postoperative randomization conditions. 3\. Expected inability to complete 12-month follow-up, no stable contact information, or inability to obtain outpatient, telephone, or inpatient follow-up data. 4\. Severe missing baseline data preventing generation of the AI risk report. 5. Concurrent participation in another interventional study that may substantially affect postoperative follow-up intensity or the primary outcome. 6\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07623213). StuddyBuddy aggregates publicly available trial information.