Acute Stanford Type A Aortic Dissection
Conditions
Interventions
Placebo:Placebo
Coenzyme Q10:Coenzyme Q10
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged =18 years; 2.Diagnosed with Stanford Type A aortic dissection confirmed by aortic CTA; 3.Onset within 24 hours; 4.The patient or legal representative refuses surgical treatment for subjective reasons; 5.The patient or their legal representative is able to understand the purpose and content of the study, the potential benefits and risks, voluntarily participate, and sign the informed consent form; 6.Agrees to cooperate with all study procedures, and consents to provide basic personal information and data generated during the study for research analysis;
Exclusion criteria
Exclusion criteria: 1.Presence of irreversible visceral or limb necrosis or organ failure; 2.Severe acute respiratory distress syndrome (ARDS) meeting all diagnostic criteria: Acute or progressive respiratory dyspnea occurring within 1 week with identifiable precipitating factors; Bilateral pulmonary infiltrates on chest X-ray or chest CT that cannot be fully explained by pleural effusion, lobar/lung atelectasis or nodules; Respiratory failure cannot be fully attributed to heart failure or excessive fluid overload. Objective examinations (e.g. echocardiography) are required to evaluate cardiogenic pulmonary edema in the absence of clinical risk factors; PaO2/FiO2 =100 mmHg; 3.Blood lactic acid >20 mmol/L; 4.Hematochezia; 5.Left ventricular ejection fraction (LVEF) <25% on echocardiography; 6.Hemoglobin <30 g/L on complete blood count; 7.Heart rate <30 beats/min or systolic blood pressure <60 mmHg, unresponsive to heart rate-increasing and blood pressure-raising medications; 8.Persistent coma for more than 2 hours; 9.Prior diagnosis of aortic dissection of any type before the current onset of aortic dissection symptoms; 10.Previous history of any cardiac or aortic surgery; 11.Traumatic etiology of aortic dissection; 12.Pregnant or lactating women; 13.Hypersensitivity to coenzyme Q10; 14.Administration of coenzyme Q10 within the previous 2 weeks; 15.Inability to cooperate with clinical study procedures due to subjective reasons (e.g. distrust in medical staff) or objective reasons (e.g. delirium, Alzheimer’s disease); 16.Participation in another clinical study prior to enrollment without completion of follow-up/withdrawal from the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 14-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;limb malperfusion;serious adverse event;all-cause mortality;cardiac tamponade;death due to aortic rupture;adverse drug reaction;aortic false lumen thrombosis;renal malperfusion;coronary artery malperfusion;mesenteric malperfusion;Suspected Unexpected Serious Adverse Reaction;spinal malperfusion;cerebral malperfusion;worsening pericardial effusion; | — |
Countries
China
Contacts
Public ContactHongjia Zhang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed