NCT02351050

Brief Summary

The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during angioplasty and stenting of coronary arteries. 120 patients indicated for coronary angioplasty and stenting will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after cardiac endovascular treatment in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD monitoring during endovascular procedure, subgroup 2 will undergo interventions without TCD monitoring. Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety these patients. We can presume that up to 50% of patients indicated for endovasular heart treatment can be treated using these methods in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

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

November 23, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

November 23, 2014

Last Update Submit

March 22, 2018

Conditions

Coronary Artery Disease

Keywords

sonolysis, brain infarction, coronary angioplasty

Outcome Measures

Primary Outcomes (1)

  • New infarction

    New brain infarction detected using magnetic resonance diffusion weighted images (MRI-DWI)

    24 hours after intervention

Secondary Outcomes (5)

  • Cognitive functions changes, measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test

    7 and 30 days after interventions

  • Large new infarction, infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI)

    24 hours after intervention

  • Volume of new brain infarction, detected using magnetic resonance diffusion weighted images (MRI-DWI)

    24 hours after intervention

  • 30-days morbidity and mortality

    30 days after intervention

  • Symptomatic intracerebral hemorrhage, detected using magnetic resonance (MRI)

    24 hours after intervention

Study Arms (2)

Sonolysis

EXPERIMENTAL

continual transcranial Doppler monitoring with maximal intensity during endovascular procedure

Device: Sonolysis

placebo

PLACEBO COMPARATOR

sham transcranial Doppler monitoring during endovascular procedure

Other: Sham procedure

Interventions

SonolysisDEVICE

continual transcranial Doppler monitoring of middle cerebral artery

Also known as: sonothrombolysis, sonothrombotripsy
Sonolysis
Sham procedureOTHER

sham transcranial Doppler monitoring of middle cerebral artery

placebo

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 35-90 years
  • sufficient temporal bone window for TCD with detectable blood flow in MCA
  • independent patient (modified Rankin score 0-2)
  • informed consent signed by the patient
  • coronary angioplasty and stenting will be performed as an elective procedure

You may not qualify if:

  • contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia)
  • emergent coronary angioplasty and stenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Nitra

Nitra, 70852, Slovakia

Location

MeSH Terms

Conditions

Coronary Artery DiseaseBrain Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • David Skoloudik, MD, Prof

    University Hospital Ostrava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2014

First Posted

January 30, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations

SL(1)