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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 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 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Guy Reeder, M.D.

Abierto para la inscripción

Contact information:

Jennifer Stortz R.N.

(507)293-9359

Stortz.Jennifer@mayo.edu

More information

Publicaciones

Publications are currently not available