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Myocardial InfarctionAPRETNCT02175836

Arrhythmia Prediction Trial

An observational study of Myocardial Infarction and Dilated Cardiomyopathy, run by University of Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 82 years
How many people
500 participants
Where
1 siteGreece
Study dates
Oct 2007to Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Heart Failure Patients with Myoacardial Infarction and Dilated Cardiomyopathy maintaining sinus rhyhtm.

Who may be able to join

  • Myocardial Infarction
  • Dilated Cardiomyopathy
  • Sinus rhythm

Who cannot join

  • Malignant diseases seriously affecting the survival
  • Conditions/diseases affecting the Autonomic Nervous System's function
  • Dementia
  • Alcoholism
  • Psychiatric diseases
  • Addiction

Trial locations and contacts

1 site in 1 country.

Petros Arsenos, MD, PhD contact

00306974338896

arspetr@otenet.gr

Greece1 site, 1 recruiting

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

    Athens, 11527

    Petros Arsenos, MD, PhD, 00306974338896, arspetr@otenet.gr

    Petros Arsenos, MD, PhD

    Recruiting

Other trials in Greece

About this study

Official title: Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.

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.

Read the 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.

Keywords
Arrhythmic Sudden Cardiac Death, Heart Failure, Risk Stratification, Autonomic Nervous System, Heart Rate, Repolarization
Medical subject headings
Myocardial Infarction, Cardiomyopathy, Dilated, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02175836
Study groupRoleWhat they receive
SCD possitive versus SCD negative groupThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death

    Measured: 2007-2019 (12 years)

Secondary outcomes (1)

  1. Total Mortality

    Measured: 2007-2019 (12 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2014 (estimated)
  2. Study startOct 2007
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02175836
Sponsor's protocol ID
17/25-10-2006
Other IDs
APRET, Athens Medical School
Acronym
APRET
Status last verified
Jan 2016
First submitted
24 Jun 2014
Last updated
28 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mirowski M, Mower MM, Langer A, Heilman MS, Schreibman J. A chronically implanted system for automatic defibrillation in active conscious dogs. Experimental model for treatment of sudden death from ventricular fibrillation. Circulation. 1978 Jul;58(1):90-4. doi: 10.1161/01.cir.58.1.90.

    PubMed 647893

  • Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

    PubMed 11907286

  • Bauer A, Barthel P, Schneider R, Ulm K, Muller A, Joeinig A, Stich R, Kiviniemi A, Hnatkova K, Huikuri H, Schomig A, Malik M, Schmidt G. Improved Stratification of Autonomic Regulation for risk prediction in post-infarction patients with preserved left ventricular function (ISAR-Risk). Eur Heart J. 2009 Mar;30(5):576-83. doi: 10.1093/eurheartj/ehn540. Epub 2008 Dec 23.

    PubMed 19109245

  • Arsenos P, Gatzoulis KA, Dilaveris P, Gialernios T, Sideris S, Lazaros G, Archontakis S, Tsiachris D, Kartsagoulis E, Stefanadis C. The rate-corrected QT interval calculated from 24-hour Holter recordings may serve as a significant arrhythmia risk stratifier in heart failure patients. Int J Cardiol. 2011 Mar 3;147(2):321-3. doi: 10.1016/j.ijcard.2010.12.076. Epub 2011 Jan 15. No abstract available.

    PubMed 21239068

  • Gatzoulis KA, Vouliotis AI, Tsiachris D, Salourou M, Archontakis S, Dilaveris P, Gialernios T, Arsenos P, Karystinos G, Sideris S, Kallikazaros I, Stefanadis C. Primary prevention of sudden cardiac death in a nonischemic dilated cardiomyopathy population: reappraisal of the role of programmed ventricular stimulation. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):504-12. doi: 10.1161/CIRCEP.113.000216. Epub 2013 Apr 15.

    PubMed 23588627

  • Arsenos P, Gatzoulis KA, Gialernios T, Dilaveris P, Tsiachris D, Archontakis S, Vouliotis AI, Raftopoulos L, Manis G, Stefanadis C. Elevated nighttime heart rate due to insufficient circadian adaptation detects heart failure patients prone for malignant ventricular arrhythmias. Int J Cardiol. 2014;172(1):e154-6. doi: 10.1016/j.ijcard.2013.12.075. Epub 2013 Dec 28. No abstract available.

    PubMed 24411917

  • Gatzoulis KA, Archontakis S, Dilaveris P, Tsiachris D, Arsenos P, Sideris S, Stefanadis C. Ventricular arrhythmias: from the electrophysiology laboratory to clinical practice. Part I: malignant ventricular arrhythmias. Hellenic J Cardiol. 2011 Nov-Dec;52(6):525-35. No abstract available.

    PubMed 22143016

  • Gatzoulis KA, Tsiachris D, Dilaveris P, Archontakis S, Arsenos P, Vouliotis A, Sideris S, Trantalis G, Kartsagoulis E, Kallikazaros I, Stefanadis C. Implantable cardioverter defibrillator therapy activation for high risk patients with relatively well preserved left ventricular ejection fraction. Does it really work? Int J Cardiol. 2013 Aug 20;167(4):1360-5. doi: 10.1016/j.ijcard.2012.04.005. Epub 2012 Apr 24.

    PubMed 22534047

  • Huikuri HV, Makikallio TH, Raatikainen MJ, Perkiomaki J, Castellanos A, Myerburg RJ. Prediction of sudden cardiac death: appraisal of the studies and methods assessing the risk of sudden arrhythmic death. Circulation. 2003 Jul 8;108(1):110-5. doi: 10.1161/01.CIR.0000077519.18416.43. No abstract available.

    PubMed 12847054

  • Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.

    PubMed 15778204

  • Wellens HJ, Schwartz PJ, Lindemans FW, Buxton AE, Goldberger JJ, Hohnloser SH, Huikuri HV, Kaab S, La Rovere MT, Malik M, Myerburg RJ, Simoons ML, Swedberg K, Tijssen J, Voors AA, Wilde AA. Risk stratification for sudden cardiac death: current status and challenges for the future. Eur Heart J. 2014 Jul 1;35(25):1642-51. doi: 10.1093/eurheartj/ehu176. Epub 2014 May 5.

    PubMed 24801071

  • Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovasc Electrophysiol. 2001 Mar;12(3):369-81. doi: 10.1046/j.1540-8167.2001.00369.x.

    PubMed 11291815

  • Gomes JA, Cain ME, Buxton AE, Josephson ME, Lee KL, Hafley GE. Prediction of long-term outcomes by signal-averaged electrocardiography in patients with unsustained ventricular tachycardia, coronary artery disease, and left ventricular dysfunction. Circulation. 2001 Jul 24;104(4):436-41. doi: 10.1161/hc2901.093197.

    PubMed 11468206

  • Merchant FM, Zheng H, Bigger T, Steinman R, Ikeda T, Pedretti RF, Salerno-Uriarte JA, Klersy C, Chan PS, Bartone C, Hohnloser SH, Ruskin JN, Armoundas AA. A combined anatomic and electrophysiologic substrate based approach for sudden cardiac death risk stratification. Am Heart J. 2013 Oct;166(4):744-52. doi: 10.1016/j.ahj.2013.06.023. Epub 2013 Sep 18.

    PubMed 24093856

  • Schwartz PJ, Wolf S. QT interval prolongation as predictor of sudden death in patients with myocardial infarction. Circulation. 1978 Jun;57(6):1074-7. doi: 10.1161/01.cir.57.6.1074.

    PubMed 639227

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction and Dilated Cardiomyopathy, run by University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Petros Arsenos, MD, PhD (00306974338896, arspetr@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death (time frame: 2007-2019 (12 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02175836, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.

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Arrhythmia Prediction Trial (NCT02175836) | AzTrials