NCT07383909 Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 1,296 participants in total. It began in 2026-01-05 with a primary completion date of 2029-01-31.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years, with no restriction on sex; 2. Diagnosis of acute Type A aortic dissection requiring emergency surgery (symptom onset \<14 days); 3. Ability to understand the study objectives, voluntary provision of written informed consent by the patient or a legally authorized representative, and willingness to comply with follow-up. Exclusion Criteria: 1. Traumatic or iatrogenic aortic dissection; 2. Previous open cardiac or thoracic aortic surgery; 3. Severe preoperative dysfunction of vital organs, such as persistent deep coma, abdominal compartment syndrome, or circulatory failure; 4. Severe comorbidities, including myocardial infarction within the past 7 days, stroke within the past 2 months; end-stage renal disease (eGFR \<30 ml/min/1.73 m²); end-stage liver disease (total bilirubin \>342 μmol/L or INR \>2.0); 5. Evidence of ischemia in the limb planned for intervention, such as decreased skin temperature, pain, pallor, with or without sensory disturbance, paralysis, or diminished/absent pulses; or severe deformity or prior arteriovenous surgery at the intervention site; 6. Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of deep vein thrombosis of the lower extremities; 7. Current use of sulfonylurea oral hypoglycemic agents or nicorandil; 8. Life expectancy \<1 year (e.g., advanced malignancy); 9. Participation in another clinical trial without having reached its primary endpoint; 10. Pregnancy or lactation; immunodeficiency (e.g., HIV positivity, history of organ transplantation); known bleeding disorders, coagulation abnormalities, or sickle cell anemia; active or uncontrolled infection; 11. Other severe physical or psychiatric disorders, or laboratory abnormalities, which in the investigator's judgment may increase risk or interfere with study outcomes, rendering the patient unsuitable for enrollment.

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