Aortic Valve Insufficiency Clinical Trial
— STAADOfficial title:
Surgical Strategy for Repair of Type A Aortic Dissection: A Multicenter Registry
Verified date | January 2024 |
Source | Centre Cardiologique du Nord |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients. In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients aged > 18 years - TAAD or intramural hematoma involving the ascending aorta - Symptoms started within 7 days from surgery - Primary surgical repair of acute TAAD - Any other major cardiac surgical procedure concomitant with surgery for TAAD. Exclusion Criteria: - Patients aged < 18 years - Onset of symptoms > 7 days from surgery - Prior procedure for TAAD - Concomitant endocarditis; - TAAD secondary to blunt or penetrating chest trauma. |
Country | Name | City | State |
---|---|---|---|
France | Francesco Nappi | Saint-Denis |
Lead Sponsor | Collaborator |
---|---|
Centre Cardiologique du Nord | Henri Mondor University Hospital, Pitié-Salpêtrière Hospital, Universita degli Studi di Genova |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of urgent procedure | Number of participants who will require scheduled procedure within 24 hours of admission. | 30-day | |
Other | Rate of emergency grade 1 | Number of participants will require procedure within 24 hours of hospital admission and who are symptomatic or minimally symptomatic with stable hemodynamic conditions and no signs of malperfusion. | 30-day | |
Other | Rate of emergency grade 2 | Number of participants who will require procedure within the first 6 hours of hospital admission due to hemodynamic instability despite use of concentration inotropes and/or malperfusion. | 30-day | |
Other | Rate of salvage grade 1 | Number of participants who will require immediate surgical procedure. Rate of cardio pulmonary resuscitation with external chest compressions and/or open cardiac massage between induction of anesthesia and initiation of cardiopulmonary bypass. | 30-day | |
Other | Rate of salvage grade 2 | Number of participants who will require immediate surgical procedure. Rate of cardiopulmonary resuscitation with external chest compressions en route to the operating theatre or prior to induction of anesthesia. | 30-day | |
Primary | Operative Mortality (OM) | Patients who died within 30 days | 30-day | |
Primary | Rate of mesenteric ischemia | Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea | 30-day | |
Primary | Rate of permanent Neurologic Deficit (PND) | Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours. | 30-day | |
Primary | Rate of composite of Major Adverse Events (MAE) | Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE) | 30-day | |
Primary | Rate of perioperative Myocardial Infarction (MI) | Number of participants with MI based on fourth universal definition. | 30-day | |
Primary | Rate of acute heart failure (AHF) | Number of participants with postoperative AHF who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device. | 30-day and in-hospital mortality | |
Secondary | Rate of Transient Neurologic Deficit (TND) | Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation | 30-day | |
Secondary | Rate of spinal Cord Injury (SCI) | Number of participants with SCI intended as rate of paraplegia and/or paraparesis | 30-day | |
Secondary | Rate of acute kidney injury | Number of participants with postoperative change in serum creatinine concentration. Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria. | 30-day | |
Secondary | Rate of perioperative bleeding | Number of participants who will receive postoperative transfused red blood cell units. The E-CABG ( coronary artery by pass grafting) classification of bleeding rate has been proposed as a simple classification of perioperative bleeding | 30-day | |
Secondary | Reoperation for bleeding | Number of participants who will receive postoperative chest reopening for excessive bleeding. | 30-day | |
Secondary | Rate of mechanical circulatory support | Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure. | 30-day | |
Secondary | Rate of composite of Major Adverse Pulmonary Events (MAPE) | Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) | 30-day | |
Secondary | Rate of reintervention | The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta. | 18-years | |
Secondary | Rate of late survival | Data on patient's survival status will be collected | 18-years |
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