Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients With AMI
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|ClinicalTrials.gov Identifier: NCT04327635|
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Attack||Drug: PEP in Acute Myocardial Infarction||Phase 1|
Patients with Acute Myocardial Infarction (AMI) who undergo percutaneous coronary intervention (PCI) at least 4 hours (but no more than 12 hours) after onset of heart attack symptoms will be treated with a single dose of PEP within 20 minutes after stent placement or post-dilation (whichever is last). Subjects will be screened at the time of emergency room presentation. From the emergency room, subjects will proceed to the cardiac catheterization laboratory where the PCI will be completed and PEP will be administered. Subjects will be followed for one year after PEP administration through clinic visits.
In the event there are patients enrolled with unknown COVID-19 status or previously negative COVID-19 status and subsequently found to be positive by SARS-Cov-2 PCR testing at visit 1, visit 4, visit 6, or any unscheduled visit within the first 14 days after receiving the study drug, then those patients will be excluded from the primary endpoint analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients With AMI (EV-AMI)|
|Estimated Study Start Date :||May 17, 2021|
|Estimated Primary Completion Date :||May 30, 2023|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: PEP in Acute Myocardial Infarction
Patients with an acute myocardial infarction who undergo cardiac catheterization at least four hours after onset of symptoms will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation.
Drug: PEP in Acute Myocardial Infarction
PEP dosage will consist of 5%, 10%, or 20% PEP. PEP dose will be infused immediately distal to the newly placed stent over approximately 5 minutes.
- Dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) of a single dose (10 mL) of PEP at escalating concentrations of extracellular vesicles delivered at a single time point (during PCI for AMI) for the treatment of downstream sequela of AMI. [ Time Frame: Days 1-14 of the study period for each study participant. ]
Dose limiting toxicities are possibly, probably or definitely related to PEP and are defined as:
- Signs of infection present in the judgement of a reviewing physician.
- CTCAE Grade 2 or higher bronchial stricture.
CTCAE Grade 3 or higher:
- New or reoccurring angina after infusion with PEP.
- Elevated ALT, AST, total or direct bilirubin, unless due to procedural complications or complications of ischemic cardiomyopathy.
- Decreased hemoglobin or platelet level, unless due to procedural complications or complications of ischemic cardiomyopathy.
- Sustained ventricular arrhythmia during PEP infusion
- Hypersensitivity or anaphylaxis during PEP infusion.
- Any other grade 3 or higher adverse event.
- Infarction scar size [ Time Frame: Day 7 and Day 40 of the study period for each study participant. ]Cardiac MRI will be used to assess myocardial infarction scar size.
- Ejection fraction [ Time Frame: Day 7 and Day 40 of the study period for each study participant. ]Cardiac MRI will be used to assess ejection fraction.
- Abdominal abnormalities [ Time Frame: Day 7 and Day 365 of the study period for each study participant. ]Complete abdominal ultrasound will be conducted to evaluate for abnormalities.
- Alloimmune Response [ Time Frame: Day 1 (Baseline/Screening) visit, Day 40 and Day 365 ]Class I & II Antibody Single Antigen Bead testing will be completed. Changes will be documented and evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327635
|Contact: Amanda M Biddle, RN, BSN, MSNemail@example.com|
|Contact: Teron T Cox, BAfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Guy S Reeder, MD||Mayo Clinic|