ICD Shock Myocardial Injuries Clinical Trial
— MYSTICOfficial title:
Myocardial Injuries and Hemodynamic Stress Biomarkers: a Comparison Between Transvenous and Subcutaneous ICD Shock
| Verified date | March 2018 |
| Source | Monaldi Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | March 1, 2019 |
| Est. primary completion date | September 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: patients who met the criteria for ICD implantation according to the current guidelines Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Monaldi Hospital | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Monaldi Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |