Clinical trial NCT00145119: CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction
Official title: Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Cardiac arrhythmias
Left ventricular dysfunction
Implantable loop recorder
Risk stratifiers
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction (\< 21 days)
* Ejection fraction \<= 40 % or wall motion index \<= 1.3

Exclusion Criteria:

* Implantable loop recorder can't be implanted within 3 weeks after MI
* NYHA class IV
* Planned or previous ICD implantation
* Planned CABG
* Severe valvular disease
* Pregnancy
* Life expectancy \< 1 year for non-cardiac cause

Primary outcomes:
measure: ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Medtronic Bakken Research Center B.V.
Study officials:
affiliation: Oulu University Central Hospital, Finland
name: H. Huikuri, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte University Hospital, Denmark
name: P. E. Bloch-Thomsen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.