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| Name | Class |
|---|---|
| Helse Stavanger HF | OTHER_GOV |
| University of Oslo | OTHER |
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The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.
This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.
The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power | ||
| 2 | Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power |
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| Measure | Description | Time Frame |
|---|---|---|
| Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek). | Registered from the monitoring function of the ICD | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. | |
| Cardiovascular mortality | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with an ICD. Inclusion from outpatient clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Torbjørn Omland, MD,PhD, MPH | Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | 1478 | Norway |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Serum, plasma and DNA
| Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| Heart failure hospitalization | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| The combination of cardiovascular mortality and heart failure hospitalizations | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.) | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |
| Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD. | Duration of follow-up will be a minimum of 180 days following inclusion of the final patient. |