Acute Coronary SyndromeNCT00955136
Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
A study testing Use of intermittent high MI impulses during echocardiogram in people with Acute Coronary Syndrome and Myocardial Infarction, run by University of Nebraska.
Trial summary
The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Use of intermittent high MI impulses during echocardiogram
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to 25 Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 30 years.
- Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
- Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.
Who cannot join
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
- Contraindication to Heart Catheterization
- Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.
About this study
The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.
Read the detailed description
Pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in STEMI.
The aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in STEMI, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Use of intermittent high MI impulses during echocardiogram
- Keywords
- ST elevated myocardial infarction, Acute coronary syndrome, MRX 801, Echocardiography
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of intermittent high MI impulses during echocardiogramDevice
Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.
| Study group | Role | What they receive |
|---|---|---|
| High MI impulses, myocardial infarction, echocardiography | Experimental | Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses. Receives: Device: Use of intermittent high MI impulses during echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.
Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009 (estimated)
- Primary completion25 Jan 2010
- Study completion25 Jan 2010
Why it stopped: The study was withdrawn due to many implementation difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Microvascular Therapeutics, LLC, The Ruth and Bruce Rappaport Faculty of Medicine, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), InCor Heart Institute, Bnai Zion Medical Center
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955136
- Sponsor's protocol ID
- 0286-09-FB
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2009
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00955136
- Acronym / sponsor ID
- 0286-09-FB
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- ST elevated myocardial infarction, Acute coronary syndrome, MRX 801, Echocardiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to many implementation difficulties.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Microvascular Therapeutics, LLC, The Ruth and Bruce Rappaport Faculty of Medicine, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), InCor Heart Institute, Bnai Zion Medical Center
- Study start
- Jul 2009 (estimated)
- Primary completion
- 25 Jan 2010 (actual)
- Study completion
- 25 Jan 2010 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.
Detailed description
Pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in STEMI.
The aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in STEMI, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High MI impulses, myocardial infarction, echocardiography | Experimental | Device: Use of intermittent high MI impulses during echocardiogramUsing the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age ≥ 30 years.
- Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
- Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
- Contraindication to Heart Catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of intermittent high MI impulses during echocardiogramUsing the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses. | Device | High MI impulses, myocardial infarction, echocardiography |
Primary outcome
Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.
Time frame: 6 weeks
Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Porter, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Use of intermittent high MI impulses during echocardiogram in people with Acute Coronary Syndrome and Myocardial Infarction, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.