CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145119
• Other study ID #: Medtronic_BRC_CRM_001
• Status: Completed
• Start date: August 2001
• Est. completion date: May 2007

Study information

• Verified date: May 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Arrhythmias, Cardiac
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Netherlands	Medtronic Bakken Research Center B.V.	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)	ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)	2 year