Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery

September 13, 2026 updated by: Liang-Wan Chen MD, Fujian Medical University

Evaluation of the Organ-Protective Effects of Remote Ischemic Preconditioning in Patients Undergoing Surgery for Acute Type A Aortic Dissection: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial

The goal of this clinical trial is to learn if a technique called remote ischemic preconditioning (RIPC) helps protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The main questions it aims to answer are:

Does RIPC reduce the risk of major complications after surgery, such as heart, brain, or kidney problems?

Is RIPC safe to use during emergency ATAAD surgery?

Researchers will compare the RIPC group to a control group (who will receive a placebo) to see if RIPC can reduce complications after surgery.

Participants will:

Receive either RIPC or a sham intervention during their surgery.

Be monitored for up to 30 days after surgery for complications.

Have follow-up visits at 3 months, 1 year, and then yearly for up to 5 years to track their recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design and Rationale

This study is a multicenter, prospective, double-blind, randomized, sham-controlled clinical trial designed to evaluate the organ-protective efficacy and safety of remote ischemic preconditioning (RIPC) in patients undergoing emergency surgery for acute type A aortic dissection (ATAAD).

Primary Objective

The primary objective of this study is to determine whether RIPC reduces the incidence of the primary composite endpoint of major adverse outcomes occurring from the time of surgery until hospital discharge (or up to 30 days postoperatively if hospitalization exceeds 30 days). This composite endpoint includes perioperative all-cause mortality and severe complications requiring invasive intervention or resulting in organ failure.

Key Interventions and Methodology Intervention Group

After induction of general anesthesia, patients in the intervention group will undergo RIPC. RIPC will be performed alternately on one upper arm and one thigh for a total of four cycles, beginning with cuff inflation on the upper arm.

Each cycle consists of 5 minutes of cuff inflation (baseline pressure of 200 mm Hg; or at least 15 mm Hg above systolic pressure if systolic pressure exceeds 185 mm Hg), followed by 5 minutes of cuff deflation to allow reperfusion. The first cycle of the thigh cuff is initiated after completion of the first inflation cycle of the upper arm cuff.

Control Group

Patients in the control group undergo a sham procedure identical in timing and application sites to the RIPC intervention. However, the cuff is inflated to a low, non-ischemic pressure of 20 mm Hg for 5 minutes, followed by 5 minutes of deflation in each cycle.

Blinding

This study employs a double-blind design. Study participants, surgical teams, postoperative care providers, outcome assessors, and data analysts/statisticians are all blinded to treatment allocation. Only an independent researcher, who does not participate in subsequent patient assessment or data collection, is unblinded in order to perform the assigned intervention.

Standardization

All surgical procedures and perioperative care are conducted in accordance with standardized protocols at each participating center.

Study Endpoints Primary Endpoint

The incidence of the primary composite endpoint of major adverse outcomes from surgery until hospital discharge (or up to 30 days postoperatively).

Secondary Endpoints

Secondary endpoints include the incidence of each individual component of the primary composite endpoint at 30 days, 3 months, and 12 months after surgery; Sequential Organ Failure Assessment (SOFA) scores recorded during the first 3 postoperative days; the incidence of postoperative delirium; durations of surgery, cardiopulmonary bypass, and mechanical ventilation; lengths of intensive care unit (ICU) and hospital stay; cardiac troponin and serum creatinine levels within the first 3 postoperative days; 12-month survival; and the incidence of unplanned rehospitalization within 12 months.

Quality Assurance and Data Management Site Selection and Training

Participating centers are required to have substantial experience in emergency ATAAD surgery. All investigators undergo centralized training on the study protocol and Standard Operating Procedures (SOPs), with a focus on the standardized RIPC procedure and data collection.

Clinical Monitoring

Clinical Research Associates (CRAs) conduct periodic on-site monitoring visits to ensure adherence to the study protocol and to verify consistency between data entered in the electronic Case Report Forms (eCRFs) and source documents.

Statistical Analysis

The primary analysis will be conducted in the intention-to-treat (ITT) population. Continuous variables will be compared using appropriate parametric or non-parametric tests, and categorical variables will be compared using the chi-square test or Fisher's exact test, as appropriate.

Sample Size Justification

Based on previously reported literature indicating an incidence of major adverse outcomes of approximately 25.8% after ATAAD surgery, and assuming an anticipated relative risk reduction of 26.5% with RIPC, sample size calculations using a two-sided alpha level of 0.05 and 80% statistical power determined that 589 evaluable patients are required per group. Allowing for an estimated dropout rate of 10%, the final target enrollment for this study is 1,312 patients.

Interim Analysis and Data Safety Monitoring

An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the study and periodically review aggregated safety data.

A pre-specified blinded sample size re-estimation will be performed when approximately 600 participants have completed assessment of the primary endpoint. This analysis will be based on the pooled event rate and observed dropout rate only, without unblinding treatment allocation or conducting between-group efficacy comparisons. Therefore, the interim analysis will not affect the overall type I error rate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Xin-fan Lin, M.D
  • Phone Number: +8617850019550
  • Email: lxf1885@163.com

Study Locations

  • China
      • Chongqing, China
        • Not yet recruiting
        • The Second Affiliated Hospital of AMU
        • Contact:
      • Shanghai, China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China
        • Recruiting
        • Xiamen Cardiovascular Hospital, Xiamen University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Heilongjian
      • Harbin, Heilongjian, China
      • Harbin, Heilongjian, China
        • Not yet recruiting
        • The Fourth Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial Chest Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Hui Jiang
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years;
  2. Acute type A aortic dissection requiring emergency surgery within 14 days of symptom onset;
  3. Written informed consent provided by the participant or a legally authorized representative;
  4. Willingness to comply with study follow-up.

Exclusion Criteria:

  1. Traumatic or iatrogenic aortic dissection;
  2. Previous open cardiac or thoracic aortic surgery;
  3. Persistent deep coma (Glasgow Coma Scale score ≤8), abdominal compartment syndrome, preoperative mechanical circulatory support, or norepinephrine-equivalent dose >0.1 μg/kg/min;
  4. Estimated glomerular filtration rate <30 mL/min/1.73 m², total bilirubin >342 μmol/L, or international normalized ratio >2.0;
  5. Evidence of ischemia in the limb planned for intervention, including decreased skin temperature, pain, or pallor, with or without sensory disturbance, paralysis, or diminished or absent peripheral pulses; severe deformity of the limb; or a history of arterial or venous surgery at the planned intervention site;
  6. Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of lower-extremity deep vein thrombosis;
  7. Current use of sulfonylureas or nicorandil;
  8. Expected survival <1 year;
  9. Concurrent participation in another clinical trial that has not yet reached its primary endpoint;
  10. Pregnancy or breastfeeding;
  11. Immunodeficiency, a known bleeding or coagulation disorder, sickle cell anemia, or active or uncontrolled infection;
  12. Any other condition considered unsuitable for enrollment by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control Group
Participants randomized to this group will receive a sham RIPC procedure. The same cuff placement and timing as the experimental group are used, but the cuff is inflated to only 20 mmHg for 5 minutes followed by 5 minutes of deflation, simulating the RIPC procedure without inducing ischemia.
Procedure: Remote ischemic preconditioning (RIPC)
This intervention is a non-invasive organ-protective procedure. After induction of general anesthesia, remote ischemic preconditioning (RIPC) will be applied to the upper arm and thigh. Both the upper arm and thigh will each undergo four ischemia-reperfusion cycles. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg-or at least 15 mmHg above the systolic blood pressure if the systolic blood pressure exceeds 185 mmHg-to induce ischemia, followed by 5 minutes of cuff deflation to allow reperfusion. The cuff inflation periods at the two sites will be staggered, beginning with the upper arm. The first thigh cuff inflation will begin after completion of the first upper-arm cuff inflation, and the alternating sequence will continue until both sites have completed four cycles. The procedure is intended to activate endogenous protective mechanisms and enhance the tolerance of vital organs to subsequent ischemic injury during surgery.
Experimental: RIPC Intervention Group
Participants randomized to this group will receive remote ischemic preconditioning (RIPC) after induction of general anesthesia. RIPC will be performed on the upper arm and thigh, with four ischemia-reperfusion cycles at each site. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg (or 15 mmHg above systolic blood pressure if systolic blood pressure exceeds 185 mmHg), followed by 5 minutes of deflation. Cuff inflation will alternate between the upper arm and thigh, beginning with the upper arm, until four cycles have been completed at each site.
Procedure: Remote ischemic preconditioning (RIPC)
This intervention is a non-invasive organ-protective procedure. After induction of general anesthesia, remote ischemic preconditioning (RIPC) will be applied to the upper arm and thigh. Both the upper arm and thigh will each undergo four ischemia-reperfusion cycles. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg-or at least 15 mmHg above the systolic blood pressure if the systolic blood pressure exceeds 185 mmHg-to induce ischemia, followed by 5 minutes of cuff deflation to allow reperfusion. The cuff inflation periods at the two sites will be staggered, beginning with the upper arm. The first thigh cuff inflation will begin after completion of the first upper-arm cuff inflation, and the alternating sequence will continue until both sites have completed four cycles. The procedure is intended to activate endogenous protective mechanisms and enhance the tolerance of vital organs to subsequent ischemic injury during surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-hospital major adverse outcomes
Time Frame: surgery to discharge or 30 days post-op

A composite of major adverse outcomes (binary). Includes:

Perioperative all-cause death;

Severe post-op complications (Grade III/IV per IAASSG consensus), involving neurological, cardiovascular, respiratory, urinary, gastrointestinal, and other systems.
surgery to discharge or 30 days post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Mechanical Ventilation
Time Frame: From end of surgery until extubation (assessed up to 30 days)
Total time from the end of surgery until successful extubation, measured in hours. Re-intubation times are included if applicable
From end of surgery until extubation (assessed up to 30 days)
Hospital Length of Stay
Time Frame: From hospital admission for surgery until hospital discharge (assessed up to 30 days)
Total duration of hospitalization after surgery, measured in days
From hospital admission for surgery until hospital discharge (assessed up to 30 days)
All-cause mortality
Time Frame: 30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
All-cause mortality
30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
Postoperative delirium
Time Frame: From the end of surgery until hospital discharge, assessed up to 30 days postoperatively
Incidence of postoperative delirium
From the end of surgery until hospital discharge, assessed up to 30 days postoperatively
Unplanned readmission
Time Frame: 30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
The proportion of patients readmitted to the hospital within the follow-up period due to causes related to the original acute type A aortic dissection or its surgical treatment, excluding planned readmissions
30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
Incidence of any individual component of the primary composite endpoint at 30 days, 90 days, and 12 months postoperatively
Time Frame: 30 days, 90 days, and 12 months postoperatively
Incidence of each individual adverse event (including death, stroke, renal failure, reoperation, etc.) that constitutes the primary composite endpoint of Major Adverse Outcomes (MAO) at 30 days, 90 days, and 12 months after surgery.
30 days, 90 days, and 12 months postoperatively
Sequential Organ Failure Assessment (SOFA) Score Within the First 3 Postoperative Days
Time Frame: From postoperative ICU admission through postoperative day 3
The Sequential Organ Failure Assessment (SOFA) score evaluates dysfunction across six organ systems: brain, respiratory, cardiovascular, liver, kidney, and hemostasis. Each organ system is scored from 0 to 4, yielding a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and a worse outcome. SOFA scores will be recorded within the first 3 postoperative days.
From postoperative ICU admission through postoperative day 3
Operative Time
Time Frame: During the surgical procedure
Operative and cardiopulmonary bypass-related time parameters, including total operative duration, cardiopulmonary bypass duration, aortic cross-clamp duration, and circulatory arrest duration. All durations will be measured in minutes.
During the surgical procedure
ICU Length of Stay
Time Frame: From ICU admission after surgery until ICU discharge (assessed up to 30 days)
Total duration of stay in the Intensive Care Unit after surgery, measured in hours
From ICU admission after surgery until ICU discharge (assessed up to 30 days)
Postoperative Serum Cardiac Troponin Concentration
Time Frame: Postoperative days 1-3
Serum cardiac troponin concentration will be measured during the first 3 postoperative days. Cardiac troponin I or cardiac troponin T will be measured according to the routine assay used at each participating center.
Postoperative days 1-3
Postoperative Serum Creatinine Concentration
Time Frame: Postoperative days 1-3
Serum creatinine concentration will be measured during the first 3 postoperative days and reported in μmol/L.
Postoperative days 1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Anhui Medical University
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
Qilu Hospital of Shandong University
Shengjing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Second Xiangya Hospital of Central South University
The First Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Xiamen University
Yan'an Affiliated Hospital of Kunming Medical University
Xiamen Cardiovascular Hospital, Xiamen University
The Fourth Affiliated Hospital of Harbin Medical University
Henan Provincial Chest Hospital
Xinqiao Hospital, Amry Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A202601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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