NCT00145119

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

January 17, 2014

Completed
Last Updated

July 2, 2025

Status Verified

May 1, 2018

Enrollment Period

5.8 years

First QC Date

September 2, 2005

Results QC Date

December 2, 2013

Last Update Submit

June 30, 2025

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionCardiac arrhythmiasLeft ventricular dysfunctionImplantable loop recorderRisk stratifiers

Outcome Measures

Primary Outcomes (1)

  • ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)

    ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

    2 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medtronic Bakken Research Center B.V.

Maastricht, Netherlands

Location

Related Publications (9)

  • 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.

    PMID: 39225437DERIVED

  • 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.

    PMID: 25755288DERIVED

  • 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.

    PMID: 24713455DERIVED

  • 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.

    PMID: 24176441DERIVED

  • 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.

    PMID: 21884874DERIVED

  • 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.

    PMID: 21093611DERIVED

  • 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.

    PMID: 20837897DERIVED

  • 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.

    PMID: 20019013DERIVED

  • 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.

    PMID: 19155249DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular Dysfunction

Results Point of Contact

Title
Director CRDM
Organization
Medtronic Bakken Research Center
+31 43 3566

Study Officials

  • H. Huikuri, Prof.

    Oulu University Central Hospital, Finland

    PRINCIPAL INVESTIGATOR

  • P. E. Bloch-Thomsen, Dr.

    Gentofte University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

August 1, 2001

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 2, 2025

Results First Posted

January 17, 2014

Record last verified: 2018-05

Locations

NL(1)