Therapeutic Use of Contrast Ultrasound in Acute Coronary Artery Disease
HUBBLE-I
High Ultrasound Mechanical Index and MicrobuBBLEs to Reduce Acute Myocardial Infarction Burden I
1 other identifier
observational
540
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedOctober 10, 2023
October 1, 2023
2 years
January 22, 2021
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic recanalization rate
Percentage of patients with acute STEMI and open artery at initial angiography (TIMI I)
At initial angiography
Secondary Outcomes (4)
Salvageability index
72-96 hours and 3 months post infarction
Overall survival
30 days post infarction
Cardiac remodeling
72-96 hours, 30 days and at 6 months
Myocardial Mechanics
72-96 hours, 30 days and at 6 months
Study Arms (5)
Subproject 1 - acute STEMI
Participants with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. Treatment will continue after procedure until complete a total of 50 minutes.
Subproject 2 - acute STEMI initially treated with fibrinolytic
Participants with acute STEMI initially treated with fibrinolytic therapy within 12 hours will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI; High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 3 - NSTEMI
Participants with NSTEMI or with high-risk unstable angina will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 4 - No reflow
Participants with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2 MI) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 6 - Pre-hospital care (ambulance)
Participants with acute STEMI routing from the ambulance to the emergency department will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Interventions
A custom designed high mechanical index (MI) impulses at 4-20 usec and \>1.0 mechanical index designed for the 1.8 MHz S5-1 transducer
Eligibility Criteria
Patients with acute ST elevation myocardial infarction (STEMI) with less than 12 hours of chest pain onset, STEMI initially treated with fibrinonilytic therapy, NSTEMI or high-risk angina undergoing early invasive PCI, anterior wall (LAD territory) acute STEMI, and acute STEMI with less than 12 hours of chest pain onset in the pre-care setting (ambulance) eligible for emergent percutaneous coronary intervention therapy.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulo General Hospitallead
- University of Nebraskacollaborator
Study Sites (2)
Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Heart Institute of Clinical Hospital of Medical School of University of Sao Paulo
São Paulo, 05403900, Brazil
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson Mathias Jr, MD, PhD
Heart Institute - University of São Paulo Medical School
- PRINCIPAL INVESTIGATOR
Jeane Tsutsui, MD, PhD
Heart Institute - University of São Paulo Medical School
- PRINCIPAL INVESTIGATOR
Thomas R Porter, MD
University of Nebraska Medical Center, Omaha, NE
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Echocardiography Laboratory - Heart Institute
Study Record Dates
First Submitted
January 22, 2021
First Posted
February 1, 2021
Study Start
February 17, 2022
Primary Completion
February 1, 2024
Study Completion
February 1, 2026
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
The data will be saved into a research encrypted platform available only to study group researchers. Participants will be non-identifiable and results will be blinded to reviewers. The platforms included are RedCap and Castor.