Trial Outcomes & Findings for Sonothrombolysis in Patients With STEMI (NCT NCT03092089)
NCT ID: NCT03092089
Last Updated: 2021-06-09
Results Overview
Spontaneous reperfusion as assessed by a pre PCI ECG complete ST-segment resolution (\>50%) (immediately prior to angiogram)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Day 1
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 8.0 • n=15 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: for patients did not have a pre PCI ECG
Spontaneous reperfusion as assessed by a pre PCI ECG complete ST-segment resolution (\>50%) (immediately prior to angiogram)
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=11 Participants
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
|
|---|---|
|
Number of Participants With Spontaneous Reperfusion
|
2 participants
|
PRIMARY outcome
Timeframe: Day 1Spontaneous reperfusion as assessed by a pre PCI TIMI 2-3 flow on diagnostic angiogram (immediately prior to angiogram)
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Number of Participants With Spontaneous Reperfusion
|
7 participants
|
SECONDARY outcome
Timeframe: Day 1Complete ST-segment resolution as assessed by the worst lead on electrocardiogram (ECG core lab)
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Number of Participants With Complete (>50%) ST-segment Resolution at 30 Minutes Post PCI
|
14 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3±2, 3 month Follow UpPopulation: EF
assessed on day 1 (pre and post reperfusion), day 3±2 (discharge) and day 90±2 days after infarction
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)
EF at 3 months
|
54.9 % ejection fraction
Standard Deviation 10.6
|
|
Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)
EF Day 3+/-2
|
54.6 % ejection fraction
Standard Deviation 9.9
|
|
Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)
EF Day 1 post PCI
|
54.5 % ejection fraction
Standard Deviation 12.2
|
|
Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)
EF Day 1 pre PCI
|
52.3 % ejection fraction
Standard Deviation 10.8
|
|
Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)
EF Day 1 admission
|
51.5 % ejection fraction
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Day 1, Day 3±2 , 3 month Follow UpPopulation: Wall Motion Score Index (WMSI)
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.
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Wall Motion Score Index (WMSI) by ECHO
WMSI 3 months
|
1.4 dimensionless
Standard Deviation 0.4
|
|
Wall Motion Score Index (WMSI) by ECHO
WMSI Day 3+/-2
|
1.5 dimensionless
Standard Deviation 0.3
|
|
Wall Motion Score Index (WMSI) by ECHO
WMSI Day 1 post PCI
|
1.6 dimensionless
Standard Deviation 0.3
|
|
Wall Motion Score Index (WMSI) by ECHO
WMSI Day 1 pre PCI
|
1.8 dimensionless
Standard Deviation 0.3
|
|
Wall Motion Score Index (WMSI) by ECHO
WMSI Day 1 admission
|
1.8 dimensionless
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Day 1, Day 3±2, 3 month Follow UpPopulation: Microvascular Perfusion Score Index (MPSI)
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.
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Microvascular Perfusion Score Index (MPSI) by ECHO
MPSI 3 months
|
1.2 dimensionless
Standard Deviation 0.2
|
|
Microvascular Perfusion Score Index (MPSI) by ECHO
MPSI Day 1 post PCI
|
1.4 dimensionless
Standard Deviation 0.3
|
|
Microvascular Perfusion Score Index (MPSI) by ECHO
MPSI Day 3+/-2
|
1.3 dimensionless
Standard Deviation 0.3
|
|
Microvascular Perfusion Score Index (MPSI) by ECHO
MPSI Day 1 pre PCI
|
1.6 dimensionless
Standard Deviation 0.2
|
|
Microvascular Perfusion Score Index (MPSI) by ECHO
MPSI Day 1 admission
|
1.7 dimensionless
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 3±2, 3 month Follow UpNumber of participants who recorded any allergic reaction to Definity
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Number of Participants With Allergic Reaction to Definity®
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Number of participants who recorded any vasospasm due to high impulse ultrasound
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Number of Participants With Vasospasm in Culprit Coronary Artery
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 3±2, 3 month Follow UpNumber of participants who recorded any adverse events that as per protocol are not related to acute myocardial infarction
Outcome measures
| Measure |
Adult Patients With High Risk STEMI
n=15 Participants
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
|
|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
Adverse Events
Adult Patients With High Risk STEMI
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Patients With High Risk STEMI
n=15 participants at risk
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
|
|---|---|
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Cardiac disorders
Ventricular Fibrillation Arrest during angiography
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Cardiac disorders
LV thrombus displayed at discharge echocardiogram
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Cardiac disorders
Congestive heart failure due to severe mitral regurgitation
|
6.7%
1/15 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Adult Patients With High Risk STEMI
n=15 participants at risk
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
|
|---|---|
|
Cardiac disorders
congestive heart failure
|
13.3%
2/15 • Number of events 3 • 3 months
|
|
Cardiac disorders
post myocardial infarct pericarditis
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
shingles
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
nausea and vomiting after morphine injection
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Nervous system disorders
Diplopia after angiography
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Cardiac disorders
small loculated pericardial effusion
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Cardiac disorders
exertional breathlessness
|
6.7%
1/15 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place