ClinicalTrials.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verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Shock with a site in Italy — 1 open to participants now, 2 under way, none of them phase 3. Shock · Italy.

Started
2018
with 1 other
Observational
6 of 13
none open now
Registered
6th of 13
by date
Lead sponsor
1 of 13
Monaldi Hospital

Among the 13 studies in Shock with a site in Italy, this one is one of 2 that started in 2018, is one of 6 observational ones, and was the 6th registered.

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

Browse Shock studies →

Open to participants now

1 of the 13 studies in Shock with a site in Italy is open now. Recruiting first, the newest first:

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 68 Shock studies recruiting now, 52 (76%) set no upper age limit and 11 (16%) stop at 75 or younger; 9 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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

03

Conditions studied

  • ICD Shock Myocardial Injuries

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04

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:

-

05

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

06

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

07

Study locations

1 site
  • Monaldi Hospital
    Naples, 80100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Sep 2018, 5 months later.

Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 5 months is below that.

Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 8, 2018
StartEst.
Apr 1, 2018
Primary completionEst.
Sep 1, 2018
CompletionEst.
Mar 1, 2019
Last update
Mar 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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