Aortic Dissection Clinical Trial
Official title:
Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection: A Pilot Study.
Aortic dissection is a life-threatening condition caused by a tear in the internal layer of major artery wall (aorta) that carries blood to all body organs, resulting in separation of the aortic wall layers (dissection). The dissected aorta compromises blood flow to any organ, and eventually leads to organ damage (Malperfusion Syndrome). Our goal in this project is to use Intravascular Ultrasound (IVUS) to have real time assessment and confirm any evidence of malperfusion syndrome in the setting of aortic dissection after repairing the original aortic tear. IVUS is a small ultrasound (sound waves) wand that is attached to the top of a thin tube. This tube is inserted into the aorta from the groin. This device takes pictures of the aorta and its major branches, to identify problems with blood flow. Having this real-time and dynamic assessment will help to identify any malperfused organs before leaving the operating room and allow us to address the malperfusion syndrome as quickly as possible to limit complications. Without this technique, identifying the problem can take several days after surgery at which point there can be irreversible complications.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with an AAD or acute on chronic aortic dissection, with a new diagnosis of malperfusion syndrome (Malperfusion Primary Cohort), by meeting both of the following criteria: - Imaging findings indicating reduced flow to the Celiac Trunk, Superior mesenteric artery, either renal artery or either iliac artery - Clinical stigmata of end organ ischemia (abdominal pain, distended abdomen, oliguria/anuria, reduced pulses, signs of limb ischemia) correlating with imaging findings - OR o Laboratory findings suggestive of end organ ischemia (lactic acidosis, elevated LFTs, Elevated Creatinine, Rhabdomyolysis, Electrolyte abnormalities) correlating with imaging findings - Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively, but who develop malperfusion syndrome due to dynamic flow changes after true lumen flow is reinstituted intraoperatively as indicated by new clinical signs or new laboratory results meeting the following criteria (Malperfusion Secondary Cohort): - New Clinical signs include: Loss of femoral pulses, distended abdomen, reduced urine output, dusky/cold extremities - New Laboratory results include: Rising lactate (>50% above baseline), Rising Creatinine, Metabolic Acidosis, Rising LFTs - Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively and postoperatively (No Malperfusion Cohort). Exclusion Criteria: - Subject has not been diagnosed with AAD, or acute on chronic aortic dissection - Subject is not hemodynamically stable to undergo IVUS evaluation - Subject has anatomy or pre-existing condition precluding safe use of IVUS evaluation - Subject has a pre-existing condition that may explain evidence of malperfusion (i.e. Dialysis patient with severe renal stenosis). - Subject or substitute decision maker has language barrier and no translator available at the time of obtaining informed consent to participate in the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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London Health Sciences Centre |
Collins JS, Evangelista A, Nienaber CA, Bossone E, Fang J, Cooper JV, Smith DE, O'Gara PT, Myrmel T, Gilon D, Isselbacher EM, Penn M, Pape LA, Eagle KA, Mehta RH; International Registry of Acute Aortic Dissection (IRAD). Differences in clinical presentati — View Citation
Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Arm — View Citation
HIRST AE Jr, JOHNS VJ Jr, KIME SW Jr. Dissecting aneurysm of the aorta: a review of 505 cases. Medicine (Baltimore). 1958 Sep;37(3):217-79. — View Citation
Kpodonu J, Ramaiah VG, Diethrich EB. Intravascular ultrasound imaging as applied to the aorta: a new tool for the cardiovascular surgeon. Ann Thorac Surg. 2008 Oct;86(4):1391-8. doi: 10.1016/j.athoracsur.2008.06.057. Review. — View Citation
Tsai T, Nienaber CA, Isselbacher EM, Trimarchi S, Bossone E, Evangelista A, Oh JK, O'Gara P, Suzuki T, Hutchison S, Cooper JV, Meinhardt G, Myrmel T, Eagle KA, Froehlich J. Acute type A aortic dissection: does a primary tear in the aortic arch affect management and outcomes? Insights from the International Registry of Acute Aortic Dissection (IRAD). Circulation 2006; 114:432.8.
Valdis M, Adams C, Chu MWA, Kiaii B, Guo L. Comparison of outcomes of root replacement procedures and supracoronary techniques for surgical repair of acute aortic dissection. Can J Surg. 2017 Jun;60(3):198-204. — View Citation
Yang B, Rosati CM, Norton EL, Kim KM, Khaja MS, Dasika N, Wu X, Hornsby WE, Patel HJ, Deeb GM, Williams DM. Endovascular Fenestration/Stenting First Followed by Delayed Open Aortic Repair for Acute Type A Aortic Dissection With Malperfusion Syndrome. Circ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Safety Endpoint | Composite of all-cause in hospital mortality, acute kidney injury requiring new dialysis, mesenteric ischemia requiring intervention and major vascular complications. | 30 days | |
Primary | Primary Effectiveness Endpoint | Composite of all-cause in hospital mortality, acute kidney injury requiring dialysis, mesenteric ischemia requiring surgical resection and major vascular complications. | 30 days | |
Secondary | Secondary Effectiveness Endpoint | Composite of length of ICU stay and length of hospitalization. | 30 days |
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