- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00376532
Extracellular Matrix Marker of Arrhythmia Risk (EMMA) (EMMA)
Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
Panoramica dello studio
Stato
Descrizione dettagliata
Sudden cardiac death (SCD) is responsible for 300,000-450,000 deaths per year in the United States. While it is well known that patients with both ischemic and non-ischemic cardiomyopathy (ICM, NICM) are at increased risk for SCD, there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients.
Myocardial scar has been validated as an arrhythmic substrate in ischemic populations; the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions. Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction.
Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix. The collagen matrix provides mechanical support to the myocardium dictating ventricular shape, size and stiffness. While typically relatively dormant, the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases (MMP).
A marker for scar burden or a marker which could assess a patient's predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population. Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker. Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Jefferson Heart Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- LVEF of ≤ 35% measured within 6 months of ICD implantation
- NYHA class II-IV at the time of ICD implantation
- ICD implantation at least 1 year prior to enrollment
Exclusion Criteria:
- Status post heart transplant
- Known malignancy in the past 2 years.
- Recent procedure, intervention or surgery within the past 90 days
- Acute MI, CABG, or PTCA/stent within the past 2 months.
- Active rheumatoid arthritis or pulmonary or hepatic fibrosis.
- Taking chronic steroid therapy for a medical condition
- Currently pregnant
- Enrolled in a concurrent study that may confound the results of this study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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ICD pacing or shock event
Subjects who experienced a device treatment, defined as a pacing event or a shock event
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No ICD pacing or shock event
Subjects who did not experience a treatment defined as a pacing event or a shock event
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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MMP-2
Lasso di tempo: At time of enrollment
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Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
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At time of enrollment
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MMP-9
Lasso di tempo: At time of enrollment
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Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
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At time of enrollment
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: David J. Whellan, MD MHS FACC, Thomas Jefferson University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TJU 06U.282
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .