NCT00196274

Brief Summary

The purpose of this study was to develope and evaluate a new method for risk stratification which predicts high mortality risk in patients with cardiac disease based on simultateous examination of high resolution ECG, continuous arterial pressure and a breathing signal.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 12, 2018

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

March 9, 2018

Conditions

Infarction, Myocardial

Keywords

AUTONOMIC NERVOUS SYSTEMAssessment, Risk

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute myocardial infarction, presence of sinus rhythm

You may not qualify if:

  • diseases (other than acute myocardial infarction) with impact on prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (7)

  • Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.

    PMID: 10227219BACKGROUND

  • Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. doi: 10.1161/01.CIR.0000088783.34082.89. Epub 2003 Aug 25.

    PMID: 12939209BACKGROUND

  • 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.

    PMID: 15778204BACKGROUND

  • Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.

    PMID: 15673543BACKGROUND

  • El-Hamad FJ, Bonabi SY, Muller A, Steger A, Schmidt G, Baumert M. Augmented Oscillations in QT Interval Duration Predict Mortality Post Myocardial Infarction Independent of Heart Rate. Front Physiol. 2020 Nov 9;11:578173. doi: 10.3389/fphys.2020.578173. eCollection 2020.

    PMID: 33240101DERIVED

  • Sinnecker D, Dirschinger RJ, Barthel P, Muller A, Morley-Davies A, Hapfelmeier A, Dommasch M, Huster KM, Hasenfuss G, Laugwitz KL, Malik M, Schmidt G. Postextrasystolic blood pressure potentiation predicts poor outcome of cardiac patients. J Am Heart Assoc. 2014 Jun 3;3(3):e000857. doi: 10.1161/JAHA.114.000857.

    PMID: 24895163DERIVED

  • Rizas KD, Nieminen T, Barthel P, Zurn CS, Kahonen M, Viik J, Lehtimaki T, Nikus K, Eick C, Greiner TO, Wendel HP, Seizer P, Schreieck J, Gawaz M, Schmidt G, Bauer A. Sympathetic activity-associated periodic repolarization dynamics predict mortality following myocardial infarction. J Clin Invest. 2014 Apr;124(4):1770-80. doi: 10.1172/JCI70085. Epub 2014 Mar 18.

    PMID: 24642467DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Georg Schmidt, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Petra Barthel, MD

    Deutsches Herzzentrum Muenchen

    STUDY DIRECTOR

  • Axel Bauer, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2000

Last Updated

March 12, 2018

Record last verified: 2005-09

Locations

DE(2)