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

NCT07623213 | Not Yet Recruiting DMC

• 1 other identifier: ATAAD-AI-RCT-001
• Study Type: interventional
• Target: 1,314
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Aortic Dissection Follow-up; Acute Type A Aortic Dissection; Stanford Type A Aortic Dissection

Keywords

Acute type A aortic dissection; ATAAD; randomized controlled trial; artificial intelligence; multimodal prediction model; intensified follow-up; aortic reintervention; adverse aortic remodeling

Outcome Measures

Primary Outcomes (1)

• 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

  From randomization to postoperative day 365

Secondary Outcomes (6)

• Aortic Reintervention Within 365 Days After Surgery

  From randomization to postoperative day 365

• Adverse Aortic Remodeling Within 365 Days After Surgery

  From randomization to postoperative day 365

• ICU Readmission Within 365 Days After Surgery

  From randomization to postoperative day 365

• Aorta-Related Mortality Within 365 Days After Surgery

  From randomization to postoperative day 365

• Unplanned Hospital Readmission Within 365 Days After Surgery

  From randomization to postoperative day 365

Study Arms (2)

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.

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.

Other: AI Prediction Model-Guided Intensified Follow-up Strategy

Interventions

Usual Postoperative Follow-up Strategy OTHER

Routine postoperative surveillance and management after acute type A aortic dissection repair according to each center's standard clinical practice.

Usual Postoperative Follow-up Strategy

AI Prediction Model-Guided Intensified Follow-up Strategy OTHER

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.

AI Prediction Model-Guided Intensified Follow-up Strategy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 years or older. 2. Acute Stanford type A aortic dissection confirmed by CTA, intraoperative findings, or medical records.
• \. Underwent open surgical repair or open repair combined with endovascular/hybrid repair.
• \. Postoperative condition is stable and the patient is planned for discharge or has entered early post-discharge follow-up.
• \. Core baseline data required for AI model operation are available, including at least one eligible preoperative or postoperative CTA imaging dataset.
• \. Able to complete telephone, outpatient, or inpatient follow-up and willing to provide written informed consent.

You may not qualify if:

• \. Predominantly chronic type A dissection, traumatic dissection, or iatrogenic dissection, if the investigator judges the patient unsuitable for this follow-up strategy study.
• \. Did not undergo surgical repair, received only palliative treatment, or did not meet postoperative randomization conditions.
• \. Expected inability to complete 12-month follow-up, no stable contact information, or inability to obtain outpatient, telephone, or inpatient follow-up data.
• \. 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.
• \. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Tongji Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Beijing Anzhen Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Related Publications (6)

• 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.

  PMID: 36003481 BACKGROUND

• Shad 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.

  PMID: 34091015 BACKGROUND

• Nappi 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.

  PMID: 38249919 BACKGROUND

• Gemelli 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.

  PMID: 35152486 BACKGROUND

• Zhou 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.

  PMID: 38424525 BACKGROUND

• Yang 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.

  PMID: 32917250 BACKGROUND

Central Study Contacts

Cai Cheng, MD, PhD

CONTACT

+8618857163588; cai.cheng@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share