T-ICD vs S-ICD Shocks: Myocardial Injuries

NCT03458065 — Unknown, 100 participants, Monaldi Hospital

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Myocardial Injuries and Hemodynamic Stress Biomarkers: a Comparison Between Transvenous and Subcutaneous ICD Shock

Registry	NCT03458065, acronym MYSTIC
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Monaldi Hospital (Other)
Conditions	ICD Shock Myocardial Injuries
Interventions	ICD (Device)
Dates	start 2018-04-01 (estimated), primary completion 2018-09-01 (estimated), completion 2019-03-01 (estimated), first posted 2018-03-08, last updated 2018-03-08
Locations	1 site in Italy

-Summary

Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). The aim of our study was to investigate the association between S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers

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+Arms and interventions

Arm	Type	Interventions	Description
S-ICD		Device: ICD
T-ICD		Device: ICD

ICD (Device): Implantable Cardioverter Defibrillator

+Outcome measures

Primary outcomes

myocardial micro-damage [6 months]: degree of myocardial micro-damage, assessed by calculating the variation in the serum levels of high-sensitivity cardiac troponin I (hs-CTnI) and creatine kinase-MB mass concentration (CK-MB mass), measured before and after an S-ICD shock delivered during intraoperative DFT

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

patients who met the criteria for ICD implantation according to the current guidelines

Exclusion Criteria:

\-

+Locations (1)

Facility	City	Country	Status
Monaldi Hospital	Naples	Italy