Abdominal Aortic Aneurysm aortic disease, atherosclerosis, chronic inflammation, lipid metabolism disorder, remodeling, rupture, aneuyrsmal wall enhancement
Conditions
Interventions
Administer Caprin HI 800 mg (2 tablets), containing 500 mg of tricaprin, three times a day after each meal (total 6 tablets/day) for two weeks. After confirming that no unpredictable intolerance sympt
C010800
nutrition therapy, oral treatment, tricaprin, Medium-chain fatty acid, reverse remodeling, rupture prevention
Sponsors
Kamba Takahito
Hirano Ken-ichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 50 - 85 years old patients at the time of consent (2) Patients diagnosed with AAA whose diameter is 30 - 45mm (rounding to the nearest integer) by enhanced computed tomography (3) Written informed consent directly by the patient
Exclusion criteria
Exclusion criteria: (1) History of AAA surgical repair, including endovascular treatment (2) Patients scheduled for surgical treatment for AAA within a year (3) Symptomatic AAA (4) AAA location excluding the infrarenal abdominal aorta (5) Sac-type AAA (6) Infected AAA, or evidence of active aortitis (7) Dissective AAA (8) Severely calcified AAA (9) Heart failure symptoms of New York Heart Association classification III-IV (10) Prognosis of less than 2 years (11) Estimated glomerular filtration rate 30 ml/min or less (12) Bronchial asthma on treatment or diagnosed with NSAIDs-exacerbated respiratory disorder (NERD) (13) A history of contrast agent allergy (14) AAA associated with connective tissue diseases (Ehlers-Danlos syndrome, Marfan syndrome, Loeys-Dietz syndrome) (15) Individuals who have been continuously consuming foods (including food oil) containing medium-chain fatty acids for more than two months and are unable to discontinue their use by the day before the initiation of Caprin HI (16) Individuals who are unable to express their own will and manage the investigational substances on their own (e.g. dementia) (17) Diagnosed with familial hypercholesterolemia (18) Other patients deemed ineligible for participation by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events Also, the additional analysis for (1) - (3) below will be performed. (1) Major adverse cardiovascular events (cardiovascular deaths, non-fatal myocardial infarction, non-fatal cerebrovascular stroke) (2) Serious abdominal aortic aneurysm-related events (persistent non-fatal acute abdominal or back pain with proven rupture, persistent non-fatal acute abdominal or back pain with unproven rupture, sudden color change in extremities with severe pain or lower extremity edema, abrupt demand for the surgical treatment, etc.) (3) Other (investigational treatment-related adverse events that cannot be classified into (1) to (2)) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following items related to efficacy indicators will be explored: (1) Changes in maximum minor short-axis diameter and aneurysm volume of abdominal aortic aneurysm (2) Analysis of the intra-aneurysmal aortic wall CT values (3) Agatston score of abdominal aortic aneurysm (measured within the same range of the aneurysm volume measurement) | — |
Contacts
Public ContactTakahito Kamba
The University of Osaka Graduate School of Medicine
Outcome results
None listed