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The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia
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| Measure | Description | Time Frame |
|---|---|---|
| ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT) | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Huikuri, Prof. | Oulu University Central Hospital, Finland | Principal Investigator |
| P. E. Bloch-Thomsen, Dr. | Gentofte University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Bakken Research Center B.V. | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39225437 | Derived | Sakthivel T, Risum N, Bundgaard H, Joergensen RM, Jacobsen UG, Huikuri HV, Thomsen PEB, Jons C, Thomsen AF. Incidentally Induced Atrial Fibrillation During Programmed Electrical Stimulation in Patients With Depressed Left Ventricular Systolic Function After an Acute Myocardial Infarction. Ann Noninvasive Electrocardiol. 2024 Sep;29(5):e70011. doi: 10.1111/anec.70011. | |
| 25755288 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT) | Posted | Number | participants | 2 year |
|
|
Other (non-serious) adverse events were not collected/ assessed
Other (non-serious) adverse events were not collected/ assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Cardiac death. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director CRDM | Medtronic Bakken Research Center | +31 43 3566 | 566 |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Jorgensen RM, Levitan J, Halevi Z, Puzanov N, Abildstrom SZ, Messier MD, Huikuri HV, Haarbo J, Thomsen PE, Jons C; CARISMA investigators. Heart rate variability density analysis (Dyx) for identification of appropriate implantable cardioverter defibrillator recipients among elderly patients with acute myocardial infarction and left ventricular systolic dysfunction. Europace. 2015 Dec;17(12):1848-54. doi: 10.1093/europace/euu394. Epub 2015 Mar 8. |
| 24713455 | Derived | Ruwald AC, Gang U, Thomsen PE, Jorgensen RM, Ruwald MH, Huikuri HV, Jons C. The predictive value of CHADS(2) risk score in post myocardial infarction arrhythmias - a Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction (CARISMA) substudy. Int J Cardiol. 2014 May 15;173(3):441-6. doi: 10.1016/j.ijcard.2014.03.010. Epub 2014 Mar 15. |
| 24176441 | Derived | Ruwald AC, Bloch Thomsen PE, Gang U, Jorgensen RM, Huikuri HV, Jons C. New-onset atrial fibrillation predicts malignant arrhythmias in post-myocardial infarction patients--a Cardiac Arrhythmias and RIsk Stratification after acute Myocardial infarction (CARISMA) substudy. Am Heart J. 2013 Nov;166(5):855-63.e3. doi: 10.1016/j.ahj.2013.08.017. Epub 2013 Sep 26. |
| 21884874 | Derived | Gang UJ, Jons C, Jorgensen RM, Abildstrom SZ, Messier MD, Haarbo J, Huikuri HV, Thomsen PE. Clinical significance of late high-degree atrioventricular block in patients with left ventricular dysfunction after an acute myocardial infarction--a Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) substudy. Am Heart J. 2011 Sep;162(3):542-7. doi: 10.1016/j.ahj.2011.06.021. Epub 2011 Aug 11. |
| 21093611 | Derived | Jons C, Jacobsen UG, Joergensen RM, Olsen NT, Dixen U, Johannessen A, Huikuri H, Messier M, McNitt S, Thomsen PE; Cardiac Arrhythmias and Risk Stratification after Acute Myocardial Infarction (CARISMA) Study Group. The incidence and prognostic significance of new-onset atrial fibrillation in patients with acute myocardial infarction and left ventricular systolic dysfunction: a CARISMA substudy. Heart Rhythm. 2011 Mar;8(3):342-8. doi: 10.1016/j.hrthm.2010.09.090. Epub 2010 Nov 18. |
| 20837897 | Derived | Bloch Thomsen PE, Jons C, Raatikainen MJ, Moerch Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Gang UJ, Hoest N, Boersma LV, Platou ES, Becker D, Messier MD, Huikuri HV; Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) Study Group. Long-term recording of cardiac arrhythmias with an implantable cardiac monitor in patients with reduced ejection fraction after acute myocardial infarction: the Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) study. Circulation. 2010 Sep 28;122(13):1258-64. doi: 10.1161/CIRCULATIONAHA.109.902148. Epub 2010 Sep 13. |
| 20019013 | Derived | Gang UJ, Jons C, Jorgensen RM, Abildstrom SZ, Haarbo J, Messier MD, Huikuri HV, Thomsen PE; CARISMA investigators. Heart rhythm at the time of death documented by an implantable loop recorder. Europace. 2010 Feb;12(2):254-60. doi: 10.1093/europace/eup383. Epub 2009 Dec 16. |
| 19155249 | Derived | Huikuri HV, Raatikainen MJ, Moerch-Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Hoest N, Boersma LV, Platou ES, Messier MD, Bloch-Thomsen PE; Cardiac Arrhythmias and Risk Stratification after Acute Myocardial Infarction study group. Prediction of fatal or near-fatal cardiac arrhythmia events in patients with depressed left ventricular function after an acute myocardial infarction. Eur Heart J. 2009 Mar;30(6):689-98. doi: 10.1093/eurheartj/ehn537. Epub 2009 Jan 20. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Diabetes | Number | participants |
|
| Ejection fraction index < 7 days after index MI | Mean | Standard Deviation | percent |
|
| Pior MI | Number | participants |
|
|
|
| 38 |
| 312 |
| 0 |
| 0 |
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| D018754 | Ventricular Dysfunction |