T-ICD vs S-ICD Shocks: Myocardial Injuries

• Conditions: ICD Shock Myocardial Injuries
• Interventions: Device: ICD

• Registration Number: NCT03458065
• Lead Sponsor: Monaldi Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Last Update Submitted: 2018-03-01
• Study First Posted: 2018-03-08
• Last Update Posted: 2018-03-08
• Study Start: 2018-04-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T-ICD	ICD	-
S-ICD	ICD	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Monaldi Hospital; 🇮🇹 Naples, Italy