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| ID | Type | Description | Link |
|---|---|---|---|
| Plasek680-2 | Registry Identifier | www.happiertrial.org |
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Problems with ensuring patient examinations defined in the protocol of the study
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| Name | Class |
|---|---|
| University Hospital Olomouc | OTHER |
| Brno University Hospital | OTHER |
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The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.
Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ischaemic cardiomyopathy | EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation | ||
| non-ischaemic cardiomyopathy | EP study,magnetic resonance imaging with LGE, ICD implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| ventricular tachyarrhytmia | ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| sudden cardiac death | death in 24-hours after symptom onset | 36-months |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | mortality from both cardiovascular and non-cardiovascular cause | 36-months |
| Cardiovascular mortality | death from strictly cardiovascular cause |
Inclusion Criteria:
Exclusion Criteria:
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Heart-failure clinic,primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Jiri Plasek, MD, PhD | Department of Cardiology,University hospital Ostrava | Study Director |
| Milos Taborsky, MD, PhD, FESC | Department of Cardiology,University Hospital Olomouc | Study Chair |
| Lubos Krivan, MD, PhD | Department of Cardiology,University Hospital Brno-Bohunice | Principal Investigator |
| Ondrej Moravec, MD | Department of Cardiology,University Hospital Olomouc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno University Hospital | Brno | 62500 | Czechia | |||
| University Hospital Olomouc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15566580 | Background | Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. doi: 10.1186/cc2948. Epub 2004 Sep 22. | |
| 16935866 | Background | Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. doi: 10.1093/europace/eul108. Epub 2006 Aug 25. No abstract available. |
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| 36-months |
| Olomouc |
| 775 20 |
| Czechia |
| University Hospital Ostrava | Ostrava | 70852 | Czechia |