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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03862339




Registration number
NCT03862339
Ethics application status
Date submitted
25/02/2019
Date registered
5/03/2019

Titles & IDs
Public title
The SoundScar Study The SOUNDSCAR Study
Scientific title
UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
Secondary ID [1] 0 0
1171
Universal Trial Number (UTN)
Trial acronym
SoundScar
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Ischemic Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Areas of abnormal contraction as determined by ICE imaging
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion criteria
* Prior heart attack (myocardial infarction) with evidence from prior non-invasive imaging demonstrating regions of the heart with reduced heart muscle function (myocardial hypokinesia/akinesia/thinning) in the absence of a non-heart attack-related (non-ischaemic) cause
* Age over 18 years
* One of the following abnormal heart rhythm (VT) events within last 6 months:
* =3 episodes of VT treated with therapeutic rapid pacing from an implantable cardiac defibrillator (antitachycardia pacing [ATP])
* =1 appropriate shocks from an implantable cardiac defibrillator
* =3 episodes of abnormal heart rhythm (VT) within 24 hours
* Sustained VT below the detection rate of the implantable cardiac defibrillator (documented by ECG/cardiac monitor)
* Sustained abnormal heart rhythm (VT) in the absence of ICD which is documented by ECG/cardiac monitor
* Patients in whom ICE imaging is planned for the clinical VT ablation procedure (clinical indication)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient unable or unwilling to provide informed consent.
* Acute heart attack (acute coronary syndrome with acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of abnormal heart rhythm (VT) - e.g. electrolyte abnormalities or drug-induced abnormal heart rhythms
* Ineligible for ablation (known to have protruding clot in the chamber of interest (left ventricular thrombus), or have implanted mechanical aortic and mitral valves)
* Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
* Pregnant patients (pregnancy test will be performed in patients who are of childbearing age who are not on an effective contraceptive prior to all VT ablation procedures)
* Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2021
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Papworth Hospital NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Saagar Mahida, MD
Address 0 0
Liverpool Heart and Chest Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03862339