Last reviewed · How we verify
NCT04599439: DEVELOP-VT
CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
trial testing Cardiac magnetic resonance imaging in Myocardial Infarction in 1,000 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Centro Medico Teknon |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 August 2020 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Cardiac magnetic resonance imaging
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Myocardial Infarction Old — all drugs for Myocardial Infarction Old →
- Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
- Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
Sponsor
Centro Medico Teknon — full company profile →
Who can join
18 and older, any sex, with Myocardial Infarction or Myocardial Infarction Old. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04599439
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cardiac magnetic resonance imaging
Trials testing the same drug.
- NCT05860504 — Acute Cardiac Dysfunction in Critical Illnes · unknown
- NCT03638271 — Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy · NA · unknown
- NCT04886713 — Adipose Tissue Inflammation in HFpEF · unknown
- NCT07331116 — Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis · completed
- NCT03516578 — CMR for Prognosis Assessment in NSTEMI · completed
Other recruiting trials for Myocardial Infarction
Currently open trials in the same condition.
- NCT07257198 — Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone · Phase 3 · recruiting
- NCT07402642 — Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome · NA · recruiting
- NCT07301034 — A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, · Phase 3 · recruiting
- NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
- NCT07138911 — Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity · NA · recruiting
Other Centro Medico Teknon trials
Trials by the same sponsor.
- NCT07159685 — Sex-Based Differences of LA: Impact on AF Ablation. · not yet recruiting
- NCT07112716 — SVC-isolation in Redo-AF Ablation With Isolated PV · NA · not yet recruiting
- NCT07402798 — Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibri · completed
- NCT07330791 — Right Phrenic Nerve Localization on CT for Ablation · completed
- NCT06730607 — Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-contr · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04599439 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centro Medico Teknon
- Last refreshed: 31 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04599439.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing