Status:
UNKNOWN
Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection
Lead Sponsor:
London Health Sciences Centre
Conditions:
Aortic Dissection
Perfusion; Complications
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 ...
Detailed Description
Acute Type A Aortic Dissection A Debakey acute type A aortic dissection (ATAAD) represents a lethal condition with a risk of mortality of 1% per hour and up to nearly 50% in first 48 hours if left un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04907071
Start Date
March 1 2022
End Date
August 1 2023
Last Update
March 2 2022
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