Arrhythmia Prediction Trial

NCT ID: NCT02175836

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2019-06-30

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.

Detailed Description

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.

Conditions

Myocardial Infarction; Dilated Cardiomyopathy; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

PETROS ARSENOS

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petros Arsenos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece

Locations

First Department of Cardiology, Medical School, National & Kapodistrian University of Athens

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Petros Arsenos, MD, PhD

Role: CONTACT

arspetr@otenet.gr

00306974338896

Facility Contacts

Petros Arsenos, MD, PhD

Role: primary

arspetr@otenet.gr

00306974338896

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Other Identifiers

APRET, Athens Medical School

Identifier Type: OTHER

Identifier Source: secondary_id

17/25-10-2006

Identifier Type: -

Identifier Source: org_study_id