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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00067953 | Other Identifier | Health Ethics Research Board |
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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
| University of Alberta | OTHER |
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This study evaluates what effect sonothrombolysis may have on spontaneous reperfusion, microvascular obstruction, left ventricular function and infarct size in patients presenting with their first ST-segment Elevation Myocardial Infarction.
This is a prospective, single center, single-arm study that examines pre-procedural sonothrombolysis as an adjuvant to contemporary therapy in patients with ST-segment elevation myocardial infarction receiving PPCI.This study is to examine what effect adding emergent diagnostic ultrasound (DUS) guided high mechanical index (HMI) impulses (sonothrombolysis), applied both before and after primary percutaneous coronary intervention (PPCI) during an intravenous commercially available microbubble infusion (Definity), have on spontaneous reperfusion (i.e. pre PCI coronary artery patency rates), microvascular obstruction, left ventricular function and infarct size in patients presenting with their first ST-segment Elevation Myocardial Infarction.
Patients will immediately receive an intravenous infusion of commercially available ultrasound contrast agent (Definity). After starting the infusion, myocardial contrast echocardiography will be performed. 4-, 2- and 3-chamber views will be recorded to document the size of the perfusion defect. Loops of 15 cardiac cycles will be recorded using low mechanical index (MI) ultrasound with a 'flash' delivered after the second cardiac cycle of the loop. The flash is a short impulse of HMI ultrasound which is transmitted to destroy the ultrasound contrast in the myocardium and then to assess the replenishment of myocardial contrast. These recordings will also be used to assess regional wall motion as well as the LV volumes and ejection fraction. Immediately after the diagnostic ultrasound, the therapeutic ultrasound will start using the same transducer by applying multiple HMI ultrasound impulses. The HMI are the same as those which are used for assessment of myocardial perfusion in diagnostic ultrasound. These pulses will be applied in the apical 4-, 2-, and 3-chamber views to the apical windows that contained the risk area. The intervals between HMI impulses will vary from 5 to 15 s depending on the time required for myocardial contrast replenishment. Diagnostic echocardiography will also be scheduled prior to discharge (Day2) and 90 days post procedure.
If this study is successful, a larger study will be designed in order to collect the evidence for using contrast ultrasound for treatment of myocardial infarction in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with high risk STEMI | Experimental | Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definity, (Lipid Microspheres) Intravenous Suspension | Drug | Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Spontaneous Reperfusion | Spontaneous reperfusion as assessed by a pre PCI ECG complete ST-segment resolution (>50%) (immediately prior to angiogram) | Day 1 |
| Number of Participants With Spontaneous Reperfusion | Spontaneous reperfusion as assessed by a pre PCI TIMI 2-3 flow on diagnostic angiogram (immediately prior to angiogram) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete (>50%) ST-segment Resolution at 30 Minutes Post PCI | Complete ST-segment resolution as assessed by the worst lead on electrocardiogram (ECG core lab) | Day 1 |
| Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Allergic Reaction to Definity® | Number of participants who recorded any allergic reaction to Definity | Day 1, Day 3±2, 3 month Follow Up |
| Number of Participants With Vasospasm in Culprit Coronary Artery |
Inclusion Criteria:
Patients presenting with STEMI within 6 hours of symptom onset and:
Are expected to receive reperfusion therapy with primary PCI
Have a high-risk STEMI ECG defined as:
Age ≥30 years.
Adequate apical and/or parasternal images by echocardiography
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Becher | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazankowski Alberta Heart Institute | Edmonton | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22178160 | Background | Slikkerveer J, Kleijn SA, Appelman Y, Porter TR, Veen G, van Rossum AC, Kamp O. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: pilot of the Sonolysis study. Ultrasound Med Biol. 2012 Feb;38(2):247-52. doi: 10.1016/j.ultrasmedbio.2011.11.001. Epub 2011 Dec 16. | |
| 19580735 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Patients With High Risk STEMI | Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI) Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Patients With High Risk STEMI | Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI) Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Spontaneous Reperfusion | Spontaneous reperfusion as assessed by a pre PCI ECG complete ST-segment resolution (>50%) (immediately prior to angiogram) | for patients did not have a pre PCI ECG | Posted | Number | participants | Day 1 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Patients With High Risk STEMI | Adult patients presenting with high-risk STEMI will receive sonothrombolysis with Definity in addition to standard of care (reperfusion therapy with PPCI) Definity, (Lipid Microspheres) Intravenous Suspension: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI Myocardial Contrast Echocardiography: Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up Repurfusion therapy with PPCI: Patients will receive reperfusion therapy with PPCI as standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Fibrillation Arrest during angiography | Cardiac disorders | Non-systematic Assessment | Defibrillation with prompt recurrence of sinus rhythm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| congestive heart failure | Cardiac disorders | Non-systematic Assessment | shortness of breath, congestive was treated with furosemide and the patient improved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kevin Bainey | University of Alberta Hospital | 780-407-2176 | Kevin.Bainey@albertahealthservices.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2017 | Apr 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2017 | Apr 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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This clinical study is a prospective single-center, single-arm investigation of sonothrombolysis in adult patients presenting with high-risk STEMI within 6 hrs of the onset of clinical symptoms and receiving reperfusion therapy with PCI. All patients will receive standard therapy. Patients will immediately receive an iv infusion of commercially available ultrasound contrast agent (Definity) and myocardial contrast echocardiography will be performed to document the size of the perfusion defect. Loops of 15 cardiac cycles will be recorded using low mechanical index (MI) ultrasound. These recordings will also be used to assess regional wall motion as well as LV volumes and ejection fraction. Immediately after the diagnostic ultrasound, the therapeutic ultrasound will start using the same transducer by applying multiple high MI ultrasound impulses. These pulses will be applied to the apical windows that contained the risk area. The intervals between HMI impulses will vary from 5 to 15 s.
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| Myocardial Contrast Echocardiography | Device | Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up |
|
| Repurfusion therapy with PPCI | Procedure | Patients will receive reperfusion therapy with PPCI as standard of care |
|
assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and day 90±2 days after infarction |
| Day 1, Day 3±2, 3 month Follow Up |
| Wall Motion Score Index (WMSI) by ECHO | Mean Regional Wall Motion Score Index assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and 90±2 days after infarction. The wall motion score is determined by visual assessment of the regional wall LV wall motion in the three apical echocardiographic views. The wall motion score of LV segments is dimensionless: normal 1, hypokinetic 2, akinetic 3, dyskinetic 4. The wall motion score index is the sum of all segmental scores divided by the number of segments analyzed (scale 1-4). A wall motion score index of 1 is normal. The worse the wall motion score index the worse is the outcome. | Day 1, Day 3±2 , 3 month Follow Up |
| Microvascular Perfusion Score Index (MPSI) by ECHO | Mean microvascular perfusion score index (MPSI) assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and 90±2 days after infarction The microvascular perfusion score is determined by visual assessment of the LV segments in the three apical echocardiographic views. The microvascular perfusion score of LV segments is dimensionless: normal 1, mildly reduced perfusion 2, no perfusion displayed 3. The microvascular perfusion score index score index is the sum of all segmental scores divided by the number of segments analyzed (scale 1 -3). A microvascular perfusion score index of 1 is normal. The worse the microvascular perfusion score index the worse is the outcome. | Day 1, Day 3±2, 3 month Follow Up |
Number of participants who recorded any vasospasm due to high impulse ultrasound
| Day 1 |
| Number of Participants With Adverse Events | Number of participants who recorded any adverse events that as per protocol are not related to acute myocardial infarction | Day 1, Day 3±2, 3 month Follow Up |
| Xie F, Lof J, Everbach C, He A, Bennett RM, Matsunaga T, Johanning J, Porter TR. Treatment of acute intravascular thrombi with diagnostic ultrasound and intravenous microbubbles. JACC Cardiovasc Imaging. 2009 Apr;2(4):511-8. doi: 10.1016/j.jcmg.2009.02.002. |
| 27160847 | Background | Roos ST, Juffermans LJ, van Royen N, van Rossum AC, Xie F, Appelman Y, Porter TR, Kamp O. Unexpected High Incidence of Coronary Vasoconstriction in the Reduction of Microvascular Injury Using Sonolysis (ROMIUS) Trial. Ultrasound Med Biol. 2016 Aug;42(8):1919-28. doi: 10.1016/j.ultrasmedbio.2016.03.032. Epub 2016 May 6. |
| 27230046 | Background | Mathias W Jr, Tsutsui JM, Tavares BG, Xie F, Aguiar MO, Garcia DR, Oliveira MT Jr, Soeiro A, Nicolau JC, Lemos PA Neto, Rochitte CE, Ramires JA, Kalil R Filho, Porter TR. Diagnostic Ultrasound Impulses Improve Microvascular Flow in Patients With STEMI Receiving Intravenous Microbubbles. J Am Coll Cardiol. 2016 May 31;67(21):2506-15. doi: 10.1016/j.jacc.2016.03.542. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Primary | Number of Participants With Spontaneous Reperfusion | Spontaneous reperfusion as assessed by a pre PCI TIMI 2-3 flow on diagnostic angiogram (immediately prior to angiogram) | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants With Complete (>50%) ST-segment Resolution at 30 Minutes Post PCI | Complete ST-segment resolution as assessed by the worst lead on electrocardiogram (ECG core lab) | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method) | assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and day 90±2 days after infarction | EF | Posted | Mean | Standard Deviation | % ejection fraction | Day 1, Day 3±2, 3 month Follow Up |
|
|
|
| Secondary | Wall Motion Score Index (WMSI) by ECHO | Mean Regional Wall Motion Score Index assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and 90±2 days after infarction. The wall motion score is determined by visual assessment of the regional wall LV wall motion in the three apical echocardiographic views. The wall motion score of LV segments is dimensionless: normal 1, hypokinetic 2, akinetic 3, dyskinetic 4. The wall motion score index is the sum of all segmental scores divided by the number of segments analyzed (scale 1-4). A wall motion score index of 1 is normal. The worse the wall motion score index the worse is the outcome. | Wall Motion Score Index (WMSI) | Posted | Mean | Standard Deviation | dimensionless | Day 1, Day 3±2 , 3 month Follow Up |
|
|
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| Secondary | Microvascular Perfusion Score Index (MPSI) by ECHO | Mean microvascular perfusion score index (MPSI) assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and 90±2 days after infarction The microvascular perfusion score is determined by visual assessment of the LV segments in the three apical echocardiographic views. The microvascular perfusion score of LV segments is dimensionless: normal 1, mildly reduced perfusion 2, no perfusion displayed 3. The microvascular perfusion score index score index is the sum of all segmental scores divided by the number of segments analyzed (scale 1 -3). A microvascular perfusion score index of 1 is normal. The worse the microvascular perfusion score index the worse is the outcome. | Microvascular Perfusion Score Index (MPSI) | Posted | Mean | Standard Deviation | dimensionless | Day 1, Day 3±2, 3 month Follow Up |
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| Other Pre-specified | Number of Participants With Allergic Reaction to Definity® | Number of participants who recorded any allergic reaction to Definity | Posted | Count of Participants | Participants | Day 1, Day 3±2, 3 month Follow Up |
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| Other Pre-specified | Number of Participants With Vasospasm in Culprit Coronary Artery | Number of participants who recorded any vasospasm due to high impulse ultrasound | Posted | Count of Participants | Participants | Day 1 |
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| Other Pre-specified | Number of Participants With Adverse Events | Number of participants who recorded any adverse events that as per protocol are not related to acute myocardial infarction | Posted | Count of Participants | Participants | Day 1, Day 3±2, 3 month Follow Up |
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|
| 0 |
| 15 |
| 3 |
| 15 |
| 6 |
| 15 |
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| LV thrombus displayed at discharge echocardiogram | Cardiac disorders | Non-systematic Assessment | Patient was admitted to initiate Warfarin treatment and intravenous heparin until therapeutic coagulation |
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| Congestive heart failure due to severe mitral regurgitation | Cardiac disorders | Non-systematic Assessment | Medical treatment for congestive heart failure and mitral valve replacement |
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| post myocardial infarct pericarditis | Cardiac disorders | Non-systematic Assessment |
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| shingles | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| nausea and vomiting after morphine injection | Gastrointestinal disorders | Non-systematic Assessment |
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| Diplopia after angiography | Nervous system disorders | Non-systematic Assessment | improved and patient referred to neurology |
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| small loculated pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| exertional breathlessness | Cardiac disorders | Non-systematic Assessment |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| MPSI Day 1 post PCI |
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