Myocardial InfarctionNCT00196300
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery
An observational study of Myocardial Infarction, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
The objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 1995to 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- acute myocardial infarction; aged >75 years
Who cannot join
- -
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 objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age.
- Conditions
- Myocardial Infarction
- Keywords
- Assessment, Risk, Autonomic nervous system, Aged
- 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 startJan 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- 500 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
- NCT00196300
- Sponsor's protocol ID
- GE IDE No. R00495
- 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 15673543
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
- Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery
- ClinicalTrials.gov ID
- NCT00196300
- Acronym / sponsor ID
- GE IDE No. R00495
- Conditions
- Myocardial Infarction
- Keywords
- Assessment, Risk, Autonomic nervous system, Aged
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jan 1995
- 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 objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- acute myocardial infarction; aged >75 years
Key exclusion criteria (1 listed)
- -
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.
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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 Myocardial Infarction, 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 NCT00196300, which also lists 4 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.