About this trial
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
This trial does not accept healthy volunteersQualifiers
1. Age 18 years or older. 2. Acute Stanford type A aortic dissection confirmed by CTA, intraoperative findings, or medical records.
Disqualifiers
1. Predominantly chronic type A dissection, traumatic dissection, or iatrogenic dissection, if the investigator judges the patient unsuitable for this follow-up strategy study.
Trial design
Parallel
Treatments tested in this trial
Usual Postoperative Follow-up Strategy
Other interventionRoutine postoperative surveillance and management after acute type A aortic dissection repair according to each center's standard clinical practice.
AI Prediction Model-Guided Intensified Follow-up Strategy
Other interventionUse of a previously developed AI multimodal prediction model to generate risk stratification for postoperative 1-year mortality and adverse aortic remodeling, triggering protocolized intensified follow-up actions when indicated.
Treatment groups
Trial outcomes
Primary outcomes
All-Cause Mortality Within 365 Days After Surgery
The proportion of randomized participants who die from any cause from randomization through postoperative day 365. Death status will be ascertained from hospital medical records, follow-up contacts, death registry information when available, and adjudicated by a blinded Clinical Event
Secondary outcomes
Aortic Reintervention Within 365 Days After Surgery
The proportion of randomized participants who undergo any clinically indicated repeat aortic intervention after randomization and through postoperative day 365. Aortic reintervention may include open surgical, endovascular, or hybrid procedures for residual or progressive dissection, aneurysmal dilation, rupture or impending rupture, malperfusion, distal anastomotic new entry, or other aorta-related complications. Events will be confirmed using operative or interventional records, hospital records, imaging data, follow-up documentation, and Clinical Event Committee adjudication.
Adverse Aortic Remodeling Within 365 Days After Surgery
The proportion of randomized participants with adverse aortic remodeling on follow-up CTA through postoperative day 365. Adverse remodeling will be determined according to the predefined imaging core laboratory and statistical analysis plan criteria, including unfavorable changes in aortic diameter, true lumen/false lumen area ratio, residual false lumen status, false lumen enlargement or persistent patency, distal anastomotic new entry, or other imaging findings meeting the study definition of adverse remodeling. Imaging findings will be reviewed by the imaging core laboratory and adjudicated when required.
ICU Readmission Within 365 Days After Surgery
The proportion of randomized participants who require readmission to an intensive care unit after randomization and through postoperative day 365. ICU readmission may occur during the index hospitalization after initial stabilization or during any subsequent hospital readmission. Events will be identified from hospital records, ICU admission records, discharge summaries, follow-up documentation, and Clinical Event Committee adjudication when required.
Aorta-Related Mortality Within 365 Days After Surgery
The proportion of randomized participants who die from an aorta-related cause after randomization and through postoperative day 365. Aorta-related death includes death attributed to aortic rupture, progression of residual dissection, aortic malperfusion, aortic expansion or remodeling, complications of aortic reintervention, or other aortic pathology. Cause of death will be determined from medical records, follow-up information, death registry data when available, and blinded Clinical Event Committee adjudication.
Locations
Sponsors and contacts
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Wuhan Asia Heart Hospital
Collaborator
Tongji Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Beijing Anzhen Hospital
Collaborator
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