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Research Plan

The Research Plan is organized at 3 target levels:

Level 1

Level 1 is comprised of a triumvirate of randomized control trials (RCTs) to study imaging-guided strategies with accepted diagnostic capabilities, but lacking wide application due to access, cost or other factors. Level I is a comparative effectiveness study of imaging-guided strategies in 2,265 patients presenting with new or progressive HF symptoms in 13 Canadian, 3 Finnish, 1 US and 3 South American sites.

Patients will be divided based on the primary clinical imaging question:

Project 1A (AIMI-HF): The primary objective is to compare the effect of HF imaging strategies on the composite clinical endpoints (CCE) of cardiac death, myocardial infarction(MI), resuscitated cardiac arrest and cardiac re-hospitalization. Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms that apply advanced (PET vs CMR) vs standard (SPECT) imaging according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices.

1A Design paper

(1,511 patients)

Project 1B: The primary objective is to compare the effect of routine cardiac magnetic resonance (CMR) versus standard care (i.e. echocardiography with only selective use of CMR) on the etiological diagnosis in patients with a non-ischemic heart failure (HF). The proposed categories of HF to be considered in this study include: idiopathic dilated cardiomyopathy, infiltrative cardiomyopathy, inflammatory, hypertrophic cardiomyopathy, heart failure with preserved ejection fraction (HFPEF), ischemic cardiomyopathy, mixed etiology and other (eg. pericardial, congenital, non-compaction, right ventricular failure).

1B Design paper

(504 patients)

Project 1C (CTA-HF): In those for whom coronary anatomy definition is required, CT will be compared to invasive coronary angiography, with resource utilization and per patient costs as the primary outcomes. Eligible HF patients with an admission to hospital or emergency room for heart failure OR a documented history of left ventricular dysfunction (LVEF <50%) OR a documented history of Class ll-lV heart failure symptoms, in the preceding 12 months prior to enrollment, in whom the diagnosis of CAD is uncertain or the definition of coronary anatomy is required for diagnosis and management.

1C Design paper

(250 patients)

View the Level I Flow Diagram (pdf)

New Inititavie: Bio-AIMI-HF:Utilizing the existing platform developed as part of IMAGE-HF, biomarker blood samples are being collected and stored. (Funding application for further collection and the cost of analysis and comparison to imaging parameters has been submitted to CIHR).

Level 2

Level 2 projects evaluate imaging approaches that are not being used clinically but provide biomarkers that may impact clinical decisions and outcomes or help understand disease and therapies.

For Project 2-A, the prognostic value of late gadolinium enhancement (LGE)-CMR defined scar for the prediction of arrhythmic events will be investigated patients awaiting primary prevention implantable cardioverter defibrillator (ICD) insertion. The primary endpoint is sudden cardiac death (SCD) or appropriate ICD shocks for ventricular tachycardia (VT)/ ventricular fibrillation (VF). Secondary endpoints include the composite clinical endpoint, all cause mortality, QoL, and costs. At Canadian sites, patients will be monitored for outcomes.

(500 patients)

View the Level 2 Flow Diagram (pdf)

Level 3

Level 3, different large animal models of HF are being applied or are under development. These will be used to enhance understanding of pathophysiology and the evaluation of imaging biomarkers. Project III-A will develop standardized large animal models of HF to enhance understanding of pathophysiology and the evaluation of imaging biomarkers. These models will be initially characterized in Finland; then disseminated to Canadian sites. Project III-B will be the lead example applying the translational platform and will evaluate novel methods to assess myocardial flow using CT and CMR in the animal models and in patients from level I and II. Future projects (III-C: RGD-peptides, Annexin; III-D: 11C-acetate PET; III-E: Hyperpolarized 13C-pyruvate CMR) will be the subject of future grant applications implementing the platform. Certain models, currently being characterized in Finland; will be translated to Canadian sites in 2012. Imaging biomarkers are being evaluated in Canadian sites using current HF models.

View the Level 3 Flow Diagram (pdf)

 
Standardization of Imaging Modalities:

5% of images (2 first and every 20th) will be transferred to a corresponding core imaging site respective to the imaging technology. The image will be interpreted by both the imaging site and core lab, and the interpretation will be compared. Discrepancies in the interpretation will be discussed amongst the team members so as to:

Find out more on the Imaging Technologies page.