Acute Myocardial InfarctionNCT00175942
Risk Indicators in Patients With Ventricular Fibrillation During Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction and Sudden Cardiac Death, run by Heidelberg University at 1 site in Germany.
Trial summary
Sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Sudden Cardiac Death
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2003to 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ST-elevation myocardial infarction ventricular fibrillation during acute MI
Who cannot join
- NSTEMI coagulation disorders, e.g.intake of coumadin
Trial locations and contacts
1 site in 1 country.
Elif Elmas, MD, Dr. contact
Martina Brückmann, MD, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Mannheim, University of Heidelberg
Mannheim, 68167
Elif Elmas, MD. Dr
About this study
Official title: Indicators of Coagulation Activation and Inflammation Contributing to Ventricular Fibrillation Complicating Acute Myocardial Infarction
Sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. Chronic elevation of indicators of coagulation activation has been found in patients with coronary heart disease , but a role of coagulation activation and proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during acute myocardial infarction has not been investigated.
Read the detailed description
Sudden cardiac death (SCD) is in most cases triggered by ischemia-related ventricular arrhythmias and is responsible for 50% of the mortality from cardiovascular disease in developed countries (1). Chronic elevation of indicators of coagulation activation and inflammation has been found in patients with coronary heart disease and may contribute to vasculatory disorders probably contributing to the development of arrhythmogenesis. However, the role of coagulation activation as a potential risk factor for ventricular fibrillation during acute myocardial infarction has not been investigated yet.
- Conditions
- Acute Myocardial Infarction, Sudden Cardiac Death
- Keywords
- acute myocardial infarction, ventricular fibrillation, coagulation, inflammation
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Thrombosis, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Carl E. Dempfle, Prof.Dr., Principal investigator, University Hospital of Mannheim, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175942
- Sponsor's protocol ID
- 0229.3
- Status last verified
- May 2005
- First submitted
- 10 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicators of Coagulation Activation and Inflammation Contributing to Ventricular Fibrillation Complicating Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00175942
- Acronym / sponsor ID
- 0229.3
- Conditions
- Acute Myocardial Infarction, Sudden Cardiac Death
- Keywords
- acute myocardial infarction, ventricular fibrillation, coagulation, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2003
- First posted
- 15 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.
Sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. Chronic elevation of indicators of coagulation activation has been found in patients with coronary heart disease , but a role of coagulation activation and proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during acute myocardial infarction has not been investigated.
Detailed description
Sudden cardiac death (SCD) is in most cases triggered by ischemia-related ventricular arrhythmias and is responsible for 50% of the mortality from cardiovascular disease in developed countries (1). Chronic elevation of indicators of coagulation activation and inflammation has been found in patients with coronary heart disease and may contribute to vasculatory disorders probably contributing to the development of arrhythmogenesis. However, the role of coagulation activation as a potential risk factor for ventricular fibrillation during acute myocardial infarction has not been investigated yet.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ST-elevation myocardial infarction ventricular fibrillation during acute MI
Key exclusion criteria (1 listed)
- NSTEMI coagulation disorders, e.g.intake of coumadin
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Elif Elmas, MD, Dr. contact
Martina Brückmann, MD, Dr. contact
Carl E. Dempfle, Prof.Dr. principal investigator
University Hospital of Mannheim, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Sudden Cardiac Death, run by Heidelberg University at 1 site 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Elmas, MD, Dr. (00496213833988), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 15 Sep 2005.