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Clinical Trials/NCT03458065
NCT03458065
Unknown
Not Applicable

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

Monaldi Hospital1 site in 1 country100 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICD Shock Myocardial Injuries
Sponsor
Monaldi Hospital
Enrollment
100
Locations
1
Primary Endpoint
myocardial micro-damage
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
March 1, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Monaldi Hospital
Responsible Party
Principal Investigator
Principal Investigator

Antonio D'Onofrio

MD, FESC

Monaldi Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

myocardial micro-damage

Time Frame: 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

Study Sites (1)

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