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Search / Trial NCT04732091

Therapeutic Use of Contrast Ultrasound in Acute Coronary Artery Disease

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jan 28, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ultrasound Sonothrombolysis Contrast Agents Microbubbles Microvascular Obstruction

ClinConnect Summary

This clinical trial is studying a new treatment approach called sonothrombolysis, which uses a special type of ultrasound combined with tiny bubbles to help restore blood flow in patients suffering from serious heart conditions like a heart attack (specifically, STEMI) or unstable angina. The goal is to see if this method is effective in improving blood flow in the heart during these acute situations. The trial will be conducted at multiple hospitals, allowing researchers to gather a wide range of data on its effectiveness.

To participate in this study, individuals must be at least 30 years old and have experienced chest pain for less than 12 hours due to a heart attack, or they may have unstable angina and be scheduled for a specific heart procedure called PCI. Participants should not have any known allergies to the ultrasound contrast agents used in the study, and they should be eligible for emergency treatment. If someone joins the trial, they can expect to receive the new treatment while being closely monitored by medical professionals. It’s important for potential participants to understand any medical conditions or treatments they have had that could affect their eligibility for this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥30 years with STEMI with less than 12 hours of chest pain onset.
  • Age ≥30 years with STEMI initially treated in a primary setting by fibrinolytic therapy within 12h
  • Age ≥30 years with NSTEMI with high-risk unstable angina who will undergo elective PCI
  • Eligible for emergent PCI therapy.
  • No contraindications or hypersensitivities to ultrasound contrast agents
  • Exclusion Criteria:
  • Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
  • Cardiogenic Shock.
  • Life expectancy of less than two months or terminally ill.
  • Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin.
  • Known large right to left intracardiac shunts or severe pulmonary hypertension.
  • Patients who received thrombolytic therapy previously to enrollment.
  • Women of childbearing potential.

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

Omaha, Nebraska, United States

Sao Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Wilson Mathias Jr, MD, PhD

Principal Investigator

Heart Institute - University of São Paulo Medical School

Jeane Tsutsui, MD, PhD

Principal Investigator

Heart Institute - University of São Paulo Medical School

Thomas R Porter, MD

Principal Investigator

University of Nebraska Medical Center, Omaha, NE

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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