Acute Type A Aortic Dissection, Postoperative Aortic Dissection Follow-up, Stanford Type A Aortic Dissection
Conditions
Keywords
Acute type A aortic dissection, ATAAD, randomized controlled trial, artificial intelligence, multimodal prediction model, intensified follow-up, aortic reintervention, adverse aortic remodeling
Brief 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.
Detailed description
Acute Stanford type A aortic dissection is a life-threatening aortic disease. Even after successful surgical repair, patients may experience death, residual dissection progression, false lumen patency, distal aortic dilation, reintervention, infection, renal dysfunction, readmission, or other adverse outcomes during the first postoperative year. Current follow-up pathways may not fully integrate longitudinal clinical, biochemical, CTA imaging, and hemodynamic/biomechanical information for individualized risk management. This study is a multicenter, prospective, randomized, controlled, open-label trial with blinded endpoint adjudication. It tests whether embedding a previously developed and validated AI multimodal prediction model into the postoperative follow-up pathway can identify high-risk patients earlier, improve completion of imaging follow-up, trigger multidisciplinary review, and support intensified management, thereby improving 1-year clinical outcomes. Eligible participants will be adults with acute Stanford type A aortic dissection who have undergone open surgery or open combined with endovascular/hybrid repair, have stable postoperative status, and are ready for discharge or early postoperative follow-up. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to usual postoperative follow-up or AI prediction model-guided intensified follow-up. Randomization is planned to be center-stratified with block randomization, with optional pre-specified stratification by early postoperative risk, DeBakey type, or Penn class according to the final randomization plan. The usual follow-up group will receive each center's standard ATAAD postoperative follow-up pathway, including discharge education, blood pressure and medication management, outpatient and telephone follow-up, and CTA or ultrasound review according to local practice. The AI-guided intensified follow-up group will receive usual follow-up plus an AI-generated risk report classifying participants as low, moderate, high, or very high risk for 1-year mortality and adverse aortic remodeling. Depending on the risk level, clinicians may arrange intensified telephone or outpatient follow-up, earlier or prioritized CTA review, multidisciplinary team discussion, reminders for blood pressure, renal function, infection or nutritional management, rapid review of abnormal imaging findings, and reintervention assessment pathways. The AI report is an auxiliary decision-support tool and does not replace guideline-based care, imaging review, or the treating surgical team's judgment. The planned total sample size is 1,314 participants, approximately 657 per group, allowing for 10% loss to follow-up or major protocol deviation. The primary endpoint is all-cause mortality from randomization through postoperative day 365. Key secondary endpoints include 1-year aortic reintervention, adverse aortic remodeling, and ICU readmission. Other secondary outcomes include aorta-related death, unplanned readmission, major adverse cardiovascular events, stroke, renal failure or continuous renal replacement therapy, infection, imaging follow-up completion, follow-up adherence, and execution of AI-triggered follow-up actions. Outcome events will be supported by hospital records, follow-up data, death registry information where available, imaging core laboratory review, AI system logs, and blinded Clinical Event Committee adjudication.
Interventions
OTHERUsual Postoperative Follow-up Strategy
Routine postoperative surveillance and management after acute type A aortic dissection repair according to each center's standard clinical practice.
OTHERAI Prediction Model-Guided Intensified Follow-up Strategy
Use 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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
The Affiliated Hospital of Qingdao University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Guangdong Provincial People's Hospital
Sir Run Run Shaw Hospital
Wuhan Asia Heart Hospital
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Renmin Hospital of Wuhan University
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Single masking: Outcomes Assessor. The Clinical Event Committee and imaging core laboratory outcome review will be blinded to treatment allocation where feasible. Participants and treating clinical teams will not be blinded because follow-up intensity differs by group.
Intervention model description
Participants will be randomized 1:1 after acute surgical treatment and clinical stabilization to either usual postoperative follow-up or AI prediction model-guided intensified follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality Within 365 Days After Surgery | From randomization to postoperative day 365 | 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
| Measure | Time frame | Description |
|---|---|---|
| Aortic Reintervention Within 365 Days After Surgery | From randomization to postoperative day 365 | 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 | From randomization to postoperative day 365 | 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 | From randomization to postoperative day 365 | 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 | From randomization to postoperative day 365 | 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. |
| Unplanned Hospital Readmission Within 365 Days After Surgery | From randomization to postoperative day 365 | The proportion of randomized participants who experience any unplanned hospital readmission after randomization and through postoperative day 365. Unplanned readmission is defined as an unscheduled inpatient admission for aortic, cardiovascular, neurological, renal, infectious, respiratory, or other clinically relevant complications. Planned admissions for routine follow-up examinations or elective pre-scheduled procedures will not be counted unless they become urgent or unplanned. Events will be confirmed using hospital records and follow-up documentation. |
| Completion Rate of Follow-up CTA Imaging Within 365 Days After Surgery | From randomization to postoperative day 365 | The proportion of randomized participants who complete at least one protocol-recommended or clinically indicated follow-up CTA examination after randomization and through postoperative day 365. CTA completion will be assessed using imaging records, DICOM availability, CRF documentation, and imaging core laboratory tracking. A CTA examination will be counted as completed if the scan is available and adequate for clinical or study-related assessment of postoperative aortic status. |
Contacts
CONTACTCai Cheng, MD, PhD
Outcome results
None listed