Acute Type A Aortic DissectionAIMS-ATAAD-FUNCT07623213
AI-Guided Intensified Follow-up After Surgery for Acute Type A Aortic Dissection
A study testing Usual Postoperative Follow-up Strategy and AI Prediction Model-Guided Intensified Follow-up Strategy in people with Acute Type A Aortic Dissection and Stanford Type A Aortic Dissection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Type A Aortic Dissection, Stanford Type A Aortic Dissection, Postoperative Aortic Dissection Follow-up
- What is being tested?
- Usual Postoperative Follow-up Strategy and AI Prediction Model-Guided Intensified Follow-up Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,314 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Artificial Intelligence Multimodal Prediction Model-Guided Intensified Follow-up Strategy for 1-Year Outcomes After Surgery for Acute Type A Aortic Dissection: A Multicenter Randomized Controlled 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.
Read the 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.
- Conditions
- Acute Type A Aortic Dissection, Stanford Type A Aortic Dissection, Postoperative Aortic Dissection Follow-up
- Being tested
- Usual Postoperative Follow-up Strategy, AI Prediction Model-Guided Intensified Follow-up Strategy
- Keywords
- Acute type A aortic dissection, ATAAD, randomized controlled trial, artificial intelligence, multimodal prediction model, intensified follow-up, aortic reintervention, adverse aortic remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Postoperative Follow-up StrategyOther
Routine 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 StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Postoperative Follow-up Strategy | Active comparator | Participants will receive the existing postoperative follow-up pathway at each center after ATAAD repair, including routine discharge education, blood pressure and medication management, outpatient or telephone follow-up, CTA or ultrasound follow-up according to center practice, and management of abnormal findings through routine clinical pathways. AI risk stratification reports will not be provided to the clinical team in this arm, except for ethically required safety information if applicable. Receives: Other: Usual Postoperative Follow-up Strategy |
| AI Prediction Model-Guided Intensified Follow-up Strategy. | Experimental | Participants will receive usual postoperative follow-up plus AI-generated risk stratification for 1-year mortality and adverse aortic remodeling. The risk report will classify participants as low, moderate, high, or very high risk. Higher-risk participants may receive more frequent follow-up, earlier or prioritized CTA review, active telephone tracking, multidisciplinary team discussion, rapid review of abnormal imaging findings, and reintervention risk assessment. The AI report is auxiliary and does not replace physician judgment. Receives: Other: AI Prediction Model-Guided Intensified Follow-up Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomization to postoperative day 365
Secondary outcomes (6)
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.
Measured: From randomization to postoperative day 365
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.
Measured: From randomization to postoperative day 365
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.
Measured: From randomization to postoperative day 365
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.
Measured: From randomization to postoperative day 365
Unplanned Hospital Readmission Within 365 Days After Surgery
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.
Measured: From randomization to postoperative day 365
Completion Rate of Follow-up CTA Imaging Within 365 Days After Surgery
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.
Measured: From randomization to postoperative day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,314 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Cheng Cai, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623213
- Sponsor's protocol ID
- ATAAD-AI-RCT-001
- Acronym
- AIMS-ATAAD-FU
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. This multicenter trial collects sensitive postoperative clinical data, laboratory results, surgical information, CTA/DICOM imaging data, AI model outputs, and follow-up outcomes from patients with acute type A aortic dissection. Data will be managed using coded study identifiers, and the linkage between study ID and personal identity will be retained only at each participating center. Access to source data will be limited to authorized investigators, study monitors, ethics committees, and regulatory authorities when required. Any future data sharing would require additional institutional approval, ethics approval, and appropriate data use agreements.
Publications
Zhu Y, Xu XY, Rosendahl U, Pepper J, Mirsadraee S. Prediction of aortic dilatation in surgically repaired type A dissection: A longitudinal study using computational fluid dynamics. JTCVS Open. 2022 Feb 9;9:11-27. doi: 10.1016/j.xjon.2022.01.019. eCollection 2022 Mar.
PubMed 36003481Shad R, Kong S, Fong R, Quach N, Kasinpila P, Bowles C, Lee A, Hiesinger W. Computational Fluid Dynamics Simulations to Predict False Lumen Enlargement After Surgical Repair of Type-A Aortic Dissection. Semin Thorac Cardiovasc Surg. 2022 Summer;34(2):443-448. doi: 10.1053/j.semtcvs.2021.05.012. Epub 2021 Jun 3.
PubMed 34091015Nappi F, Gambardella I, Singh SSA, Salsano A, Santini F, Spadaccio C, Biancari F, Dominguez J, Fiore A. Survival following acute type A aortic dissection: a multicenter study. J Thorac Dis. 2023 Dec 30;15(12):6604-6622. doi: 10.21037/jtd-23-1137. Epub 2023 Dec 21.
PubMed 38249919Gemelli M, Di Tommaso E, Chivasso P, Sinha S, Ahmed EM, Rajakaruna C, Bruno VD. Blood lactate predicts mortality after surgical repair of type A acute aortic dissection. J Card Surg. 2022 May;37(5):1206-1211. doi: 10.1111/jocs.16324. Epub 2022 Feb 13.
PubMed 35152486Zhou T, Li JX, Zhang CY, Li YG, Peng J, Wei CL, Chen MH, Zhou HF. Risk factors for one-year mortality following discharge in patients with acute aortic dissection: development and validation of a predictive model in a cross-sectional study. BMC Cardiovasc Disord. 2024 Feb 29;24(1):129. doi: 10.1186/s12872-024-03766-6.
PubMed 38424525Yang Y, Xue J, Li H, Tong J, Jin M. Perioperative risk factors predict one-year mortality in patients with acute type-A aortic dissection. J Cardiothorac Surg. 2020 Sep 11;15(1):249. doi: 10.1186/s13019-020-01296-8.
PubMed 32917250
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Multimodal Prediction Model-Guided Intensified Follow-up Strategy for 1-Year Outcomes After Surgery for Acute Type A Aortic Dissection: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07623213
- Acronym / sponsor ID
- AIMS-ATAAD-FU / ATAAD-AI-RCT-001
- Conditions
- Acute Type A Aortic Dissection, Stanford Type A Aortic Dissection, Postoperative Aortic Dissection Follow-up
- Keywords
- Acute type A aortic dissection, ATAAD, randomized controlled trial, artificial intelligence, multimodal prediction model, intensified follow-up, aortic reintervention, adverse aortic remodeling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,314 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- 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 start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Postoperative Follow-up Strategy | Active comparator | Other: Usual Postoperative Follow-up StrategyParticipants will receive the existing postoperative follow-up pathway at each center after ATAAD repair, including routine discharge education, blood pressure and medication management, outpatient or telephone follow-up, CTA or ultrasound follow-up according to center practice, and management of abnormal findings through routine clinical pathways. AI risk stratification reports will not be provided to the clinical team in this arm, except for ethically required safety information if applicable. |
| AI Prediction Model-Guided Intensified Follow-up Strategy. | Experimental | Other: AI Prediction Model-Guided Intensified Follow-up StrategyParticipants will receive usual postoperative follow-up plus AI-generated risk stratification for 1-year mortality and adverse aortic remodeling. The risk report will classify participants as low, moderate, high, or very high risk. Higher-risk participants may receive more frequent follow-up, earlier or prioritized CTA review, active telephone tracking, multidisciplinary team discussion, rapid review of abnormal imaging findings, and reintervention risk assessment. The AI report is auxiliary and does not replace physician judgment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Postoperative Follow-up StrategyRoutine postoperative surveillance and management after acute type A aortic dissection repair according to each center's standard clinical practice. | Other | Usual Postoperative Follow-up Strategy |
| AI Prediction Model-Guided Intensified Follow-up StrategyUse 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. | Other | AI Prediction Model-Guided Intensified Follow-up Strategy. |
Primary outcome
All-Cause Mortality Within 365 Days After Surgery
Time frame: 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
6 secondary outcomes
Aortic Reintervention Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
Adverse Aortic Remodeling Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
ICU Readmission Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
Aorta-Related Mortality Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
Unplanned Hospital Readmission Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
Completion Rate of Follow-up CTA Imaging Within 365 Days After Surgery
Time frame: From randomization to postoperative day 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 36003481Zhu Y, Xu XY, Rosendahl U, Pepper J, Mirsadraee S. Prediction of aortic dilatation in surgically repaired type A dissection: A longitudinal study using computational fluid dynamics. JTCVS Open. 2022 Feb 9;9:11-27. doi: 10.1016/j.xjon.2022.01.019. eCollection 2022 Mar.
- Background: PubMed 34091015Shad R, Kong S, Fong R, Quach N, Kasinpila P, Bowles C, Lee A, Hiesinger W. Computational Fluid Dynamics Simulations to Predict False Lumen Enlargement After Surgical Repair of Type-A Aortic Dissection. Semin Thorac Cardiovasc Surg. 2022 Summer;34(2):443-448. doi: 10.1053/j.semtcvs.2021.05.012. Epub 2021 Jun 3.
- Background: PubMed 38249919Nappi F, Gambardella I, Singh SSA, Salsano A, Santini F, Spadaccio C, Biancari F, Dominguez J, Fiore A. Survival following acute type A aortic dissection: a multicenter study. J Thorac Dis. 2023 Dec 30;15(12):6604-6622. doi: 10.21037/jtd-23-1137. Epub 2023 Dec 21.
- Background: PubMed 35152486Gemelli M, Di Tommaso E, Chivasso P, Sinha S, Ahmed EM, Rajakaruna C, Bruno VD. Blood lactate predicts mortality after surgical repair of type A acute aortic dissection. J Card Surg. 2022 May;37(5):1206-1211. doi: 10.1111/jocs.16324. Epub 2022 Feb 13.
- Background: PubMed 38424525Zhou T, Li JX, Zhang CY, Li YG, Peng J, Wei CL, Chen MH, Zhou HF. Risk factors for one-year mortality following discharge in patients with acute aortic dissection: development and validation of a predictive model in a cross-sectional study. BMC Cardiovasc Disord. 2024 Feb 29;24(1):129. doi: 10.1186/s12872-024-03766-6.
- Background: PubMed 32917250Yang Y, Xue J, Li H, Tong J, Jin M. Perioperative risk factors predict one-year mortality in patients with acute type-A aortic dissection. J Cardiothorac Surg. 2020 Sep 11;15(1):249. doi: 10.1186/s13019-020-01296-8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. This multicenter trial collects sensitive postoperative clinical data, laboratory results, surgical information, CTA/DICOM imaging data, AI model outputs, and follow-up outcomes from patients with acute type A aortic dissection. Data will be managed using coded study identifiers, and the linkage between study ID and personal identity will be retained only at each participating center. Access to source data will be limited to authorized investigators, study monitors, ethics committees, and regulatory authorities when required. Any future data sharing would require additional institutional approval, ethics approval, and appropriate data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Postoperative Follow-up Strategy and AI Prediction Model-Guided Intensified Follow-up Strategy in people with Acute Type A Aortic Dissection and Stanford Type A Aortic Dissection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cai Cheng, MD, PhD (+8618857163588, cai.cheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality Within 365 Days After Surgery (time frame: From randomization to postoperative day 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07623213, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.