A Study to Evaluate the Safety of Intracoronary Infusion of Extracellular Vesicles in Patients with Acute Myocardial Infarction

Overview

About this study

The purpose of this study is to determine the acute and long-term dose limiting toxicities of intracoronary infused PEP and the maximum tolerated dose in a cohort of coronary stent implantation patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Ages 21-85 years old.
  • 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 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 childbearing potential who is unwilling to agree to use acceptable contraception methods for 3 months after receiving the investigational drug.
  • Pacemaker/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 testing within the last 30 days.
  • DNR/DNI status prior to PCI procedure or planned DNR/DNI status after PCI procedure.
  • Homeless or no permanent address at the time of enrollment.

Eligibility last updated 6/13/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Guy Reeder, M.D.

Open for enrollment

Contact information:

Jennifer Stortz R.N.

(507)293-9359

Stortz.Jennifer@mayo.edu

More information

Publications

Publications are currently not available