Sonothrombolysis in Patients With STEMI

NCT03092089 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ST2017-Pro00067953Pro00067953
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

Sonothrombolysis, STEMI, PPCI, Microbubbles

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Number of Participants With Complete (>50%) ST-segment Resolution at 30 Minutes Post PCI

  Day 1

• Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method)

  Day 1, Day 3±2, 3 month Follow Up

• Wall Motion Score Index (WMSI) by ECHO

  Day 1, Day 3±2 , 3 month Follow Up

• Microvascular Perfusion Score Index (MPSI) by ECHO

  Day 1, Day 3±2, 3 month Follow Up

Other Outcomes (3)

• Number of Participants With Allergic Reaction to Definity®

  Day 1, Day 3±2, 3 month Follow Up

• Number of Participants With Vasospasm in Culprit Coronary Artery

  Day 1

• Number of Participants With Adverse Events

  Day 1, Day 3±2, 3 month Follow Up

Study Arms (1)

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)

Drug: Definity, (Lipid Microspheres) Intravenous Suspension; Device: Myocardial Contrast Echocardiography; Procedure: Repurfusion therapy with PPCI

Interventions

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

Adult patients with high risk STEMI

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

Adult patients with high risk STEMI

Repurfusion therapy with PPCI PROCEDURE

Patients will receive reperfusion therapy with PPCI as standard of care

Adult patients with high risk STEMI

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
• ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4mm
• Age ≥30 years.
• Adequate apical and/or parasternal images by echocardiography

You may not qualify if:

• Isolated inferior STEMI without anterior ST-segment depression
• Previous coronary bypass surgery
• Cardiogenic shock
• Known or suspected hypersensitivity to ultrasound contrast agent used for the study
• 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.

Sponsors & Collaborators

• Harald Becher: lead
• Alberta Health services: collaborator
• University of Alberta: collaborator

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Location

Related Publications (4)

• 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.

  PMID: 22178160 BACKGROUND

• 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.

  PMID: 19580735 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.

  PMID: 27160847 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.

  PMID: 27230046 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

perflutren

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr Kevin Bainey
• Organization: University of Alberta Hospital

Kevin.Bainey@albertahealthservices.ca

780-407-2176

Study Officials

• Harald Becher

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 27, 2017
• Study Start: August 15, 2017
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)