RECRUITING

Therapeutic Use of Contrast Ultrasound in Acute Coronary Artery Disease

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Conditions

Acute Myocardial InfarctionUnstable AnginaUltrasoundSonothrombolysisContrast agentsMicrobubblesMicrovascular obstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Preclinical studies have demonstrated that high mechanical index (MI) impulses from a diagnostic ultrasound (DUS) transducer during an intravenous microbubble infusion (sonothrombolysis) can restore epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI). The investigators propose to demonstrate the clinical effectiveness of sonothrombolysis in multiple centers and in a wide scenario of acute coronary syndromes.

Official Title

High Ultrasound Mechanical Index and MicrobuBBLEs to Reduce Acute Myocardial Infarction Burden I

Quick Facts

Study Start:2022-02-17
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04732091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Study Contact

Wilson Mathias Jr, MD, PhD
CONTACT
5511- 984155556
wmathias@incor.usp.br
Jeane M Tsutsui, MD, PhD
CONTACT
5511-993806992
jeane.tsutsui@incor.usp.br

Principal Investigator

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

Study Locations (Sites)

Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Sao Paulo General Hospital

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-17
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2022-02-17
Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

  • Ultrasound
  • Sonothrombolysis
  • Contrast agents
  • Microbubbles
  • Microvascular obstruction

Additional Relevant MeSH Terms

  • Acute Myocardial Infarction
  • Unstable Angina