Autonomic Regulation Trial (ART)

NCT ID: NCT00196274

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infarction, Myocardial

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

acute myocardial infarction, presence of sinus rhythm

Exclusion Criteria

diseases (other than acute myocardial infarction) with impact on prognosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Principal Investigators

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Georg Schmidt, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Petra Barthel, MD

Role: STUDY_DIRECTOR

Deutsches Herzzentrum Muenchen

Axel Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 10227219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12939209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15778204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15673543 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33240101 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24895163 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24642467 (View on PubMed)

Other Identifiers

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BMBF13N7705/2

Identifier Type: -

Identifier Source: secondary_id

GE IDE No. R00500

Identifier Type: -

Identifier Source: org_study_id

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