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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
Sponsor:
Collaborator:
Rion LLC
Information provided by (Responsible Party):
Christopher J. McLeod, Mayo Clinic

Brief Summary:
Determine the safety of up to 3 dose levels of a study drug called PEP in patients who have had a recent (within the last 12 hours) heart attack.

Condition or disease Intervention/treatment Phase
Heart Attack Drug: PEP in Acute Myocardial Infarction Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.
Other Names:
  • PEP in AMI
  • STEMI
  • Heart Attack
  • Myocardial Infarction
  • Acute Myocardial Infarction




Primary Outcome Measures :
  1. 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:

    1. Signs of infection present in the judgement of a reviewing physician.
    2. CTCAE Grade 2 or higher bronchial stricture.
    3. CTCAE Grade 3 or higher:

      1. New or reoccurring angina after infusion with PEP.
      2. Elevated ALT, AST, total or direct bilirubin, unless due to procedural complications or complications of ischemic cardiomyopathy.
      3. Decreased hemoglobin or platelet level, unless due to procedural complications or complications of ischemic cardiomyopathy.
      4. Sustained ventricular arrhythmia during PEP infusion
      5. Hypersensitivity or anaphylaxis during PEP infusion.
      6. Any other grade 3 or higher adverse event.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 21-85
  • Males and females
  • Acute myocardial infarction (ST elevation at the J point in at least 2 contiguous leads of

    ≥2 mm (0.2 mV) in men or ≥1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥1 mm (0.1 mV) in other contiguous chest leads or the limb leads)

  • Successful stent implantation within 4 and 12 hours from onset of AMI symptoms
  • Angiographic evidence of TIMI 0 or TIMI 1 flow through culprit lesion prior to stent placement
  • Angiographic evidence of residual stenosis visually <30% after stent placement
  • Willing and able to provide signed informed consent

Exclusion Criteria:

  • Prior cardiovascular history of systolic or diastolic dysfunction or acute myocardial infarction
  • Received fibrinolytic therapy (i.e. tPA (tissue plasminogen activator)), prior to PCI
  • Known history of stroke or TIA within the past 6 months
  • Prior solid organ transplantation at any time
  • Pregnant or lactating at screening
  • Known presence of chronic systemic inflammatory disorder that requires ongoing therapy with immunosuppressive agents
  • Known immune system compromise including but not limited to human immunodeficiency virus (HIV), hepatitis A, hepatitis B (HBV) or hepatitis C (HCV) infection
  • Known history of malignancy of any type except non-melanoma skin cancer
  • Known serum creatinine >2 mg/dL or GFR ≤30 mL/min within the last twelve months
  • Known AST, ALT, and/or bilirubin (total) elevated twice the upper limit of normal for age & gender within the last twelve months
  • Known Hemoglobin lower than 8.0 g/dL within the last twelve months
  • Known current illicit drug use at screening
  • Other major surgical procedure or major trauma within the previous 14 days prior to enrollment
  • Female of child bearing potential who is unwilling to agree to use acceptable contraception methods for 3 months after receiving the investigational drug
  • ICD implant in place
  • Adult lacking decision-making capacity
  • Prisoner
  • Non-English speaking
  • English-speaking but illiterate
  • Legally blind
  • Known allergy to heparin or heparin-induced thrombocytopenia
  • Known history of positive SARS-CoV2 PCR nasal swab test

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda M Biddle, RN, BSN, MSN 507-538-5428 biddle.amanda@mayo.edu
Contact: Teron T Cox, BA 507-293-9466 cox.teron@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Christopher J. McLeod
Rion LLC
Investigators
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Principal Investigator: Guy S Reeder, MD Mayo Clinic
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher J. McLeod, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04327635    
Other Study ID Numbers: 18-011636
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD, related data dictionaries, and all IPD that underlie results in a publication available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Prior to study initiation, the study protocol and informed consent form will be provided to Rion, LLC. During the study, all safety reports (as they happen or quarterly), and all SAEs as they happen will be reported to Rion, LLC. At the end of the study after database is locked, a formal clinical study report will be provided to Rion, LLC.
Access Criteria: IPD will only be shared with the collaborator, Rion, LLC.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases