Cardiac MRI in the prediction of outcomes in advanced cardiomyopathy

Not Applicable

Recruiting

• Conditions: Heart Failure; Sudden cardiac death; Arrhythmia; Cardiac fibrosis; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000727448
• Lead Sponsor: Baker IDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Age > 18
2.Capable of giving informed consent
3.New or established ICM or NICM (LVEF < or = 45%) as detected on any cardiac imaging (echocardiogram, nuclear medicine scan, other cardiac MRI, LV angiogram)

Exclusion Criteria

1.Unable to consent to study
2.Contraindication to cardiac MRI (eg, existing ICD, uncontrollable claustrophobia, inability to lie flat, proven or suspected metallic implant)
3.eGRF < 35ml/min or Cr > 220
4.Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death will be assessed by review of the medical records and confirmed with reference to publicly available official registries (e.g. Registry of Births Death and Marriages)[0, 6, 12, 24, 36, 48, 60 months];Sudden cardiac death - assessed by evaluation of the official cause of death on death certificate or coroners report and complemented with further information from the relevant medical record where available.[0, 6, 12, 24, 36, 48, 60 months];Aborted sudden cardiac death (survived cardiac arrest) - assessed by review of the medical record for the relevant admission, or by review of ICD interrogation data (ie stored interrogation data) - in the setting of appropriate therapy for VT of VF.[0, 6, 12, 24, 36, 48, 60 months]

Secondary Outcome Measures

Name	Time	Method
All cause mortality[0, 6, 12, 24, 36, 48, 60 months];Documented ventricular tachycardia or ventricular fibrillation - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).[0, 6, 12, 24, 36, 48, 60 months];New onset other arrhythmias (AF, SVT, other) - - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).[0, 6, 12, 24, 36, 48, 60 months];Left Ventricular Ejection Fraction - as documented in subsequent transthoracic echocardiograms, gated blood pool scans, other cardiac MRI, LV angiography or any other validated LV ejection function assessment.[0, 6, 12, 24, 36, 48, 60 months];Functional status as determined by he New York Heart Association Scale - as determined by the medical record.[0, 6, 12, 24, 36, 48, 60 months]