NCT00828698

Brief 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.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

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

January 1, 1996

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
Last Updated

January 26, 2009

Status Verified

January 1, 2009

Enrollment Period

4 years

First QC Date

January 23, 2009

Last Update Submit

January 23, 2009

Conditions

Keywords

Death, suddenAll cause mortality

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    10years

Secondary Outcomes (1)

  • Sudden cardiac death

    10 years

Study Arms (1)

Acute Myocardial Infarction patients

Other: No intervention

Interventions

Acute Myocardial Infarction patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients who have been hospitalized for acute myocardial infarction from Munich, Germany and Oulu, Finland

You may qualify if:

  • Diagnosis of acute myocardial infarction
  • Consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oulu University Hospital

Oulu, FIN-90014, Finland

Location

Deutsches Herzzentrum

Munich, D-80636, Germany

Location

Related Publications (4)

  • 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.

  • Bauer 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.

  • 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.

  • Peltola 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples from Finnish subjects in the study have been retained.

MeSH Terms

Conditions

Death, Sudden

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 1996

Primary Completion

January 1, 2000

Last Updated

January 26, 2009

Record last verified: 2009-01

Locations