NCT04217304

Brief Summary

This study will assess the safety and feasibility of sonothrombolysis in the acute management of STEMI undergoing reperfusion therapy with systemic fibrinolysis as part of a pharmacoinvasive approach

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

January 2, 2020

Last Update Submit

March 2, 2026

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Complete ST-Segment Resolution

    ST-segment recovery as assessed by complete ST-segment resolution (\>50%)

    90 minutes post TNK administration

Secondary Outcomes (8)

  • Frequency of rescue/urgent PCI

    approximately 3-24 hours post TNK administration

  • ST-segment resolution (>50%)

    approximately 30 minutes post TNK administration

  • ST-segment resolution (continuous)

    approximately 30 minutes post TNK administration

  • Left ventricular ejection fraction

    Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.

  • Wall motion score index (WMSI)

    Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.

  • +3 more secondary outcomes

Other Outcomes (3)

  • Composite of death/shock, heart failure/new myocardial infarction in hospital

    Until hospital discharge, approximately 5 days

  • Composite of death/shock, heart failure/new myocardial infarction at 1-year

    1 year

  • TIMI flow grade pre and post PCI on index angiogram

    pre and post PCI on index angiogram, approximately 3-24 hours post TNK administration

Study Arms (2)

Sonothrombolysis

EXPERIMENTAL

Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis

Drug: Definity® with High Mechanical Index Ultrasound

Standard of Care

NO INTERVENTION

Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®

Interventions

Definity® with High Mechanical Index UltrasoundDRUG

Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion

Sonothrombolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 fibrinolysis
  • Have a high-risk STEMI ECG as defined as:
  • \>2mm ST-segment elevation in 2 anterior or lateral leads; or
  • \>2mm 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 2. Previous coronary bypass surgery 3. Cardiogenic shock 4. Known or suspected hypersensitivity to ultrasound contrast agent used for the study 5. Life expectancy of less than two months or terminally ill 6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin 7. Known large right to left intracardiac shunts 8. Patient received another investigational medication or treatment within 30 days prior to presentation with STEMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

perflutren

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 3, 2020

Study Start

February 23, 2021

Primary Completion

January 19, 2026

Study Completion

January 19, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)