Acute Myocardial InfarctionNCT00145119

CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

An observational study of Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myocardial Infarction
How many people: 312 participants
Where: 1 siteNetherlands
Study dates: Aug 2001to May 2007
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Medtronic Bakken Research Center B.V.
Maastricht

Other trials in Netherlands

About this study

Official title: Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction

Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction, Cardiac arrhythmias, Left ventricular dysfunction, Implantable loop recorder, Risk stratifiers
Medical subject headings: Arrhythmias, Cardiac, Ventricular Dysfunction, Left

What is being measured

The primary outcome is the main question the study is designed to answer.

ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)
ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)
Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2001May 2007

First posted5 Sep 2005 (estimated)
Study startAug 2001
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00145119
Sponsor's protocol ID: Medtronic_BRC_CRM_001
Status last verified: May 2018
First submitted: 2 Sep 2005
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 39225437
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.
PubMed 25755288
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.
PubMed 24713455
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.
PubMed 24176441
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.
PubMed 21884874
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.
PubMed 21093611
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.
PubMed 20837897
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.
PubMed 20019013
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.
PubMed 19155249

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT00145119
Acronym / sponsor ID: Medtronic_BRC_CRM_001
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction, Cardiac arrhythmias, Left ventricular dysfunction, Implantable loop recorder, Risk stratifiers
Study type: Observational
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Aug 2001
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 5 Sep 2005 (estimated)
Results: Posted 17 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

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

ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)
Time frame: 2 year
ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

Results and safety

Results posted to the registry on 17 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients	312	267

Primary outcome: ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)

Time frame: 2 year. Number. Unit: participants

Measure	Patients n = 312
Primary endoints	25
Sudden death	8
Resuscitated cardiac arrest	3
Syncope	2
Symptomatic sustained VT	12

Patients: proportion (%): 8

Adverse events

Time frame: Other (non-serious) adverse events were not collected/ assessed. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients	38 of 312 (12.2%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39225437Sakthivel 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.
Derived from this study: PubMed 25755288Jorgensen 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.
Derived from this study: PubMed 24713455Ruwald 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.
Derived from this study: PubMed 24176441Ruwald 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.
Derived from this study: PubMed 21884874Gang 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.
Derived from this study: PubMed 21093611Jons 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.
Derived from this study: PubMed 20837897Bloch 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.
Derived from this study: PubMed 20019013Gang 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.
Derived from this study: PubMed 19155249Huikuri 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.

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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.

H. Huikuri, Prof. principal investigator

Oulu University Central Hospital, Finland

P. E. Bloch-Thomsen, Dr. principal investigator

Gentofte University Hospital, Denmark

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, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

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 2 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jul 2025. 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 Netherlands. 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?

Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00145119, which also lists 9 linked publications.

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 2 Jul 2025.