NCT03458065

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

March 1, 2018

Last Update Submit

March 1, 2018

Conditions

ICD Shock Myocardial Injuries

Outcome Measures

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

    6 months

Study Arms (2)

S-ICD

Device: ICD

T-ICD

Device: ICD

Interventions

ICDDEVICE

Implantable Cardioverter Defibrillator

S-ICDT-ICD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monaldi Hospital

Naples, 80100, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FESC

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 8, 2018

Study Start

April 1, 2018

Primary Completion

September 1, 2018

Study Completion

March 1, 2019

Last Updated

March 8, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)