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CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04599439
Acronym
DEVELOP-VT
Enrollment
1000
Registered
2020-10-22
Start date
2020-08-01
Completion date
2025-09-30
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Myocardial Infarction, Myocardial Infarction Old, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia, Ventricular Arrythmia, Ventricular Tachycardia

Keywords

myocardial infarction, cardiac magnetic resonance imaging, scar arrhythmogenicity, ventricular arrhythmias, sudden cardiac death, border zone channels

Brief summary

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (\> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years. In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

Interventions

DIAGNOSTIC_TESTCardiac magnetic resonance imaging

All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.

Sponsors

Centro Medico Teknon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years. * Chronic (\> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF. * Life expectancy of \> 1 year with a good functional status. * Signed informed consent.

Exclusion criteria

* Age \< 18 years. * Pregnancy. * Life expectancy of \< 1 year, or bad functional status (NYHA IV functional class). * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo a contrast-enhanced CMR study. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Ventricular arrhythmias or sudden cardiac death2 yearsClinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.

Secondary

MeasureTime frameDescription
Non-cardiac causes of mortality2 yearsDeath due to non-cardiac conditions
Heart failure hospitalization rate2 yearsHospitalization due to decompensated heart failure

Countries

Spain

Contacts

Primary ContactAntonio Berruezo, MD, PhD
antonio.berruezo@quironsalud.es(+34) 93 290 62 51
Backup ContactBeatriz Jáuregui, MD
beatriz.jauregui@quironsalud.es(+34) 93 290 62 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026