Acute Myocardial InfarctionFINGERNCT00828698
FINGER; Finland-Germany Myocardial Infarction Study
An observational study of Acute Myocardial Infarction, run by University of Oulu at 2 sites in 2 countries.
Trial summary
The purpose of this observational study is to find characteristics and risk stratification methods for identification of subjects who have increased risk of death, especially sudden cardiac death, after acute myocardial infarction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 1996to Jan 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients who have been hospitalized for acute myocardial infarction from Munich, Germany and Oulu, Finland
Who may be able to join
- Diagnosis of acute myocardial infarction
- Consent to the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Finnish-German Prospective, Observational Follow-up Study on Risk Assessment of Mortality After Myocardial Infarction
The purpose of this observational study is to find characteristics and risk stratification methods for identification of subjects who have increased risk of death, especially sudden cardiac death, after acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- No intervention
- Keywords
- Death, sudden, All cause mortality
- Medical subject headings
- Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Acute Myocardial Infarction patients | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 10years
Secondary outcomes (1)
Sudden cardiac death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 1996
- Primary completionJan 2000
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 Acute 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
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Council of the Finnish Academy of Science, Finnish Foundation for Cardiovascular Research, Bundesministerium für Bildung, Wissenschaft, Forschung und Technologie, Kommission für Klinische Forschung, German Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828698
- Sponsor's protocol ID
- Finger-96
- Acronym
- FINGER
- Status last verified
- Jan 2009
- First submitted
- 23 Jan 2009
- Last updated
- 26 Jan 2009
- Results posted
- No
Publications
Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Perkiomaki JS, Schmidt G, Huikuri HV. Frequency of sudden cardiac death among acute myocardial infarction survivors with optimized medical and revascularization therapy. Am J Cardiol. 2006 Feb 15;97(4):480-4. doi: 10.1016/j.amjcard.2005.09.077. Epub 2005 Dec 22.
PubMed 16461041Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
PubMed 16714188Makikallio 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 15778204Peltola M, Tulppo MP, Kiviniemi A, Hautala AJ, Seppanen T, Barthel P, Bauer A, Schmidt G, Huikuri HV, Makikallio TH. Respiratory sinus arrhythmia as a predictor of sudden cardiac death after myocardial infarction. Ann Med. 2008;40(5):376-82. doi: 10.1080/07853890701884659.
PubMed 18499938
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish-German Prospective, Observational Follow-up Study on Risk Assessment of Mortality After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00828698
- Acronym / sponsor ID
- FINGER / Finger-96
- Conditions
- Acute Myocardial Infarction
- Keywords
- Death, sudden, All cause mortality
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Medical Council of the Finnish Academy of Science, Finnish Foundation for Cardiovascular Research, Bundesministerium für Bildung, Wissenschaft, Forschung und Technologie, Kommission für Klinische Forschung, German Research Foundation
- Study start
- Jan 1996
- Primary completion
- Jan 2000 (actual)
- First posted
- 26 Jan 2009 (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 observational study is to find characteristics and risk stratification methods for identification of subjects who have increased risk of death, especially sudden cardiac death, after acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myocardial Infarction patients | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients who have been hospitalized for acute myocardial infarction from Munich, Germany and Oulu, Finland
Key inclusion criteria (2 listed)
- Diagnosis of acute myocardial infarction
- Consent to the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Acute Myocardial Infarction patients |
Primary outcome
All cause mortality
Time frame: 10years
1 secondary outcome
Sudden cardiac death
Time frame: 10 years
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 26 Jan 2009.
- Results publication: PubMed 16461041Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Perkiomaki JS, Schmidt G, Huikuri HV. Frequency of sudden cardiac death among acute myocardial infarction survivors with optimized medical and revascularization therapy. Am J Cardiol. 2006 Feb 15;97(4):480-4. doi: 10.1016/j.amjcard.2005.09.077. Epub 2005 Dec 22.
- Results publication: PubMed 16714188Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
- Results publication: 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.
- Results publication: PubMed 18499938Peltola M, Tulppo MP, Kiviniemi A, Hautala AJ, Seppanen T, Barthel P, Bauer A, Schmidt G, Huikuri HV, Makikallio TH. Respiratory sinus arrhythmia as a predictor of sudden cardiac death after myocardial infarction. Ann Med. 2008;40(5):376-82. doi: 10.1080/07853890701884659.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by University of Oulu at 2 sites in 2 countries.
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 2 inclusion and 0 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 26 Jan 2009. 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 Finland, 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.
What does the primary outcome measure?
All cause mortality (time frame: 10years). 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 NCT00828698, 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 26 Jan 2009.