Arrhythmia Prediction Trial (APRET)
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| ClinicalTrials.gov Identifier: NCT02175836 |
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Recruitment Status : Unknown
Verified January 2016 by PETROS ARSENOS, University of Athens.
Recruitment status was: Recruiting
First Posted : June 26, 2014
Last Update Posted : January 28, 2016
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Sponsor:
University of Athens
Information provided by (Responsible Party):
PETROS ARSENOS, University of Athens
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Brief Summary:
Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.
| Condition or disease |
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| Myocardial Infarction Dilated Cardiomyopathy Heart Failure |
Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function [ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens. |
| Study Start Date : | October 2007 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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SCD possitive versus SCD negative group
The total Heart Failure patients subgroup experiencing Sudden Cardiac Death surrogate end-points during follow up versus the patients subgroup that is free from Sudden Cardiac Death surrogate end-points.
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Primary Outcome Measures :
- Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death [ Time Frame: 2007-2019 (12 years) ]
Secondary Outcome Measures :
- Total Mortality [ Time Frame: 2007-2019 (12 years) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years to 82 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Heart Failure Patients with Myoacardial Infarction and Dilated Cardiomyopathy maintaining sinus rhyhtm.
Criteria
Inclusion Criteria:
- Myocardial Infarction
- Dilated Cardiomyopathy
- Sinus rhythm
Exclusion Criteria:
- Malignant diseases seriously affecting the survival
- Conditions/diseases affecting the Autonomic Nervous System's function
- Dementia
- Alcoholism
- Psychiatric diseases
- Addiction
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175836
Contacts
| Contact: Petros Arsenos, MD, PhD | 00306974338896 | arspetr@otenet.gr |
Locations
| Greece | |
| First Department of Cardiology, Medical School, National & Kapodistrian University of Athens | Recruiting |
| Athens, Greece, 11527 | |
| Contact: Petros Arsenos, MD, PhD 00306974338896 arspetr@otenet.gr | |
| Principal Investigator: Petros Arsenos, MD, PhD | |
Sponsors and Collaborators
University of Athens
Investigators
| Principal Investigator: | Petros Arsenos, MD, PhD | First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece |
Additional Information:
Publications:
Publications:
| Responsible Party: | PETROS ARSENOS, MD, PhD, University of Athens |
| ClinicalTrials.gov Identifier: | NCT02175836 |
| Other Study ID Numbers: |
17/25-10-2006 APRET, Athens Medical School ( Other Identifier: Athens Medical School ) |
| First Posted: | June 26, 2014 Key Record Dates |
| Last Update Posted: | January 28, 2016 |
| Last Verified: | January 2016 |
Keywords provided by PETROS ARSENOS, University of Athens:
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Arrhythmic Sudden Cardiac Death Heart Failure Risk Stratification |
Autonomic Nervous System Heart Rate Repolarization |
Additional relevant MeSH terms:
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Heart Failure Myocardial Infarction Cardiomyopathies Cardiomyopathy, Dilated Infarction Heart Diseases Cardiovascular Diseases Ischemia |
Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases Cardiomegaly Laminopathies Genetic Diseases, Inborn |