ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000727448

Ethics application status

Approved

Date submitted

22/05/2016

Date registered

2/06/2016

Date last updated

2/06/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Cardiac MRI in the prediction of outcomes in advanced cardiomyopathy

Scientific title

Cardiac MRI in the prediction of outcomes in advanced cardiomyopathy

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1165-9147

Trial acronym

PREDICT-MRI

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart Failure

Sudden cardiac death

Arrhythmia

Cardiac fibrosis

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

5

Target follow-up type

Years

Description of intervention(s) / exposure

Cardiomyopathy - both newly diagnosed and established. Both ischaemic and non-ischaemic. We will follow outcomes for 5 years. Patients undergo a cardiac MRI evaluating heart function including the presence of focal and diffuse scarring, left ventricular function, and chamber dimensions. Follow up will be via assessment of the avaialble medical records.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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)

Timepoint [1]

0, 6, 12, 24, 36, 48, 60 months

Primary outcome [2]

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.

Timepoint [2]

0, 6, 12, 24, 36, 48, 60 months

Primary outcome [3]

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.

Timepoint [3]

0, 6, 12, 24, 36, 48, 60 months

Secondary outcome [1]

All cause mortality

Timepoint [1]

0, 6, 12, 24, 36, 48, 60 months

Secondary outcome [2]

Documented ventricular tachycardia or ventricular fibrillation - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).

Timepoint [2]

0, 6, 12, 24, 36, 48, 60 months

Secondary outcome [3]

New onset other arrhythmias (AF, SVT, other) - - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).

Timepoint [3]

0, 6, 12, 24, 36, 48, 60 months

Secondary outcome [4]

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.

Timepoint [4]

0, 6, 12, 24, 36, 48, 60 months

Secondary outcome [5]

Functional status as determined by he New York Heart Association Scale - as determined by the medical record.

Timepoint [5]

0, 6, 12, 24, 36, 48, 60 months

Eligibility

Key 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)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key 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

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Using a non-inferiority margin of 2.0 for the hazard ratio of ICD implantation to no ICD implantation in NICM patients without myocardial scar, and assuming a similar 3-year mortality to that published in prior studies, approximately 240 patients would need to be enrolled (120 with a primary prevention ICD and 120 without) to achieve a statistical power of 0.8. We have previously demonstrated a high rate of appropriate ICD discharge of approximately 15% per year. 1 Assuming approximately half of these discharges were life saving, 110 patients in each group will deliver a power of 80% with an alpha value of 5%.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/04/2016

Date of last participant enrolment

Anticipated

30/04/2021

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

240

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Baker IDI Heart and Diabetes Institute

Address [1]

75 Commercial Road
Melbourne, VIC, 3004

Country [1]

Australia

Primary sponsor type

Other

Name

Baker IDI Heart and Diabetes Institute

Address

75 Commercial Road
Melbourne, VIC, 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Road
Melbourne, VIC, 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2015

Approval date [1]

21/04/2015

Ethics approval number [1]

7/15

Summary

Brief summary

Nearly 50% of patients with systolic heart failure suffer sudden cardiac death (SCD). In patients with ischaemic cardiomyopathy (ICM) and an LV ejection fraction (LVEF) of <30%, primary prevention ICD implantation reduced mortality at 20 months follow-up compared to medical therapy alone. Trials in NICM patients suggested similar findings but failed to reach statistical significance - statistical significance was only achieved when both ICM and NICM groups were combined. urrent clinically based guidelines focus on the importance of symptoms (NYHA Class) and LVEF in determining suitability for ICD implantation. Nonetheless, ICD implantation, despite its mortality benefit in selected patient populations, infers significant morbidity in terms or device related complications including tamponade, infections, inappropriate device therapy (which itself has been linked to increased mortality). Consequently, uptake of prophylactic ICD therapy in Australia has been variable with many major centres failing to comply with international guidelines. Hence, many authors have called for the urgent re-evaluation of current guidelines. Clearly there is a need for further risk stratification to assess the vulnerability of the heart failure population to sudden cardiac death, and other long term morbidities associated with the condition.
Myocardial fibrosis is a fundamental event in the development of cardiac failure, and is a common feature in all patients with advanced cardiac failure regardless of the aetiology of cardiomyopathy. Myocardial fibrosis in animal models is associated with worsening ventricular systolic function, abnormal cardiac remodelling and may predispose to ventricular arrhythmia. Also, increasing myocardial fibrosis results in progressive deterioration of myocardial function, with more extensive myocardial fibrosis identified histologically in the hearts of patients with advanced heart failure. Cardiac fibrosis has been identified as a key component of remodelling associated particularly idiopathic cardiomyopathy and our group has demonstrated a clear association with arrhythmogenesis (including VT and VF) in patients with systolic heart failure. For example, recently, our group published compelling data supporting the role of contrast-enhanced cardiac magnetic resonance imaging (CMR) in identifying low risk patients who meet current criteria for ICD implantation yet are unlikely to benefit this intervention. We feel that the cardiac MRI evaluation, particularly its ability to detect both regional and diffuse fibrosis, may be a useful tool in predicting the outcomes of patients with heart failure.
This trail seeks to establish a long term prospective data registry to evaluate predictive value of CMR in determining the long term outcome of patients with advanced cardiomyopathy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andrew J Taylor

Address

Head Cardiac MRI
Alfred Hospital and Baker IDI
75 Commercial Road
Melbourne, VIC, 3004

Country

Australia

Phone

+61390762000

Fax

Email

[email protected]

Contact person for public queries

Name

Sandeep Prabhu

Address

Alfred Hospital Heart Centre
3rd Floor Philip Block
The Alfred
55 Commercial Road
Prahran, VIC, 3181

Country

Australia

Phone

+61 3 90762000

Fax

Email

[email protected]

Contact person for scientific queries

Name

Andrew J Taylor

Address

Head Cardiac MRI
Alfred Hospital and Baker IDI
75 Commercial Road
Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 90762000

Fax

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.