CClinicalTrials.gg
Status unknownNCT03458065MYSTICUpdated Mar 8, 2018

T-ICD vs S-ICD Shocks: Myocardial Injuries

An observational study in ICD Shock Myocardial Injuries, sponsored by Monaldi Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-08.

Sponsored by Monaldi Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • ICD Shock Myocardial Injuries
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • S-ICD

    Device: ICD

  • T-ICD

    Device: ICD

Interventions

  • DeviceICD

    Implantable Cardioverter Defibrillator

05

What researchers measure

Primary outcomes

  1. myocardial micro-damage

    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

    Time frame: 6 months

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Study locations

1 site
  • Monaldi Hospital
    Naples, 80100, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03458065
Lead sponsor
Monaldi Hospital
Responsible party
Antonio D'Onofrio (MD, FESC, Monaldi Hospital) — Principal investigator
First posted
Mar 8, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
Sep 1, 2018 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Mar 8, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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