Infarction, MyocardialNCT00196274
Autonomic Regulation Trial (ART)
An observational study of Infarction, Myocardial, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infarction, Myocardial
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- May 2000to not given
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myocardial infarction, presence of sinus rhythm
Who cannot join
- diseases (other than acute myocardial infarction) with impact on prognosis
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Muenchen
Munich, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, 81675
About this study
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.
- Conditions
- Infarction, Myocardial
- Keywords
- AUTONOMIC NERVOUS SYSTEM, Assessment, Risk
- Medical subject headings
- Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infarction, MyocardialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Georg Schmidt, MD, Study chair, Deutsches Herzzentrum MuenchenPetra Barthel, MD, Study director, Deutsches Herzzentrum MuenchenAxel Bauer, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196274
- Sponsor's protocol ID
- GE IDE No. R00500
- Other IDs
- BMBF13N7705/2
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 12 Mar 2018
- Results posted
- No
Publications
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.
PubMed 10227219Barthel 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.
PubMed 12939209Makikallio 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 15778204Bauer 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.
PubMed 15673543El-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.
PubMed 33240101Sinnecker 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.
PubMed 24895163Rizas 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.
PubMed 24642467
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Regulation Trial (ART)
- ClinicalTrials.gov ID
- NCT00196274
- Acronym / sponsor ID
- GE IDE No. R00500
- Conditions
- Infarction, Myocardial
- Keywords
- AUTONOMIC NERVOUS SYSTEM, Assessment, Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- May 2000
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute myocardial infarction, presence of sinus rhythm
Key exclusion criteria (1 listed)
- diseases (other than acute myocardial infarction) with impact on prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Background: PubMed 10227219Schmidt 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.
- Background: PubMed 12939209Barthel 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.
- Background: PubMed 15778204Makikallio 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.
- Background: PubMed 15673543Bauer 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.
- Derived from this study: PubMed 33240101El-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.
- Derived from this study: PubMed 24895163Sinnecker 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.
- Derived from this study: PubMed 24642467Rizas 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.
Related trials for Infarction, Myocardial
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schmidt, MD study chair
Deutsches Herzzentrum Muenchen
Petra Barthel, MD study director
Deutsches Herzzentrum Muenchen
Axel Bauer, MD principal investigator
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infarction, Myocardial, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196274, which also lists 7 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 12 Mar 2018.