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Projects

IMAGE-HF is organized at three target levels, the first two involving human clinical research. Level 3 evaluating animal models of heart failure.

For more information on the levels, please refer to the Research Plan page.

Level 1
Project 1A

Project 1B
Project 1C
Bio-AIMI-HF (New Initiative)

Level 2
Project 2A

Project 1A:
Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF)

The primary objective of AIMI-HF is to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging.

Major Secondary objectives

To compare the effect of HF imaging strategies on

  1. The incidence of revascularization procedures (PCI, CABG)
  2. LV remodeling: LV volumes, LVEF
  3. HF symptoms, NYHA class
  4. QOL (MLHFQ, the EQ5D) and health economics.
  5. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.

Overall study design

AIMI-HF is the IMAGE-HF Project 1-A trial; it is a prospective comparative effectiveness study to compare the effect of HF imaging strategies in patients with HF due to IHD. Eligible patients will have LV systolic dysfunction due to IHD where evaluation of ischemia and viability is relevant. Patients will be prospectively randomized to standard (SPECT) versus advanced (PET or CMR) imaging. Patients who meet inclusion criteria but cannot be randomized due to clinical management decisions, yet undergo standard or advanced imaging (SPECT, PET/CT or CMR), will be entered into a registry. Based on site screening logs, patients who could not be randomized, who met all other inclusion criteria and underwent standard or advanced imaging, will be retrospectively enrolled, from the date of original HREB approval, into the study as registry participants. Registry recruitment will be monitored to ensure a balanced recruitment for each modality registry.

AIMI-HF provides an image-guided management platform that is uniquely and ideally suited to enable the evaluation of emerging imaging strategies and biomarkers, identifying key targets for future imaging trials.

Study Population

Patients (n=1,511) with a clinical diagnosis of heart failure, who need further definition of ischemia, viability or scar and meet the following Inclusion/Exclusion criteria:

Inclusion criteria

Exclusion criteria

ClinicalTrials.gov Identifier: NCT01288560

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Project 1B:
Routine versus selective cardiac magnetic resonance in non-ischemic heart failure:study protocol for a randomized controlled trial (OUTSMART-HF).

Primary objective: 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).

Secondary objectives: Determine the effects that routine use of CMR in non-ischemic HF has on therapeutic decisions, on the Composite Clinical Endpoint (CCE), cardiac function, symptoms, quality of life (QoL), and costs. Ancillary measurements will include the safety of imaging tests and adverse reactions to gadolinium contrast agent.

Study Population

Project 1B is a randomized controlled trial comparing i) routine CMR vs. ii) echocardiography with selective CMR in 504 patients with HF due to NICM and/or HFpEF.

Study Population will consist of patients with either i) Newly diagnosed HF within the past 12 months OR ii) Established HF patients with deterioration/decompensation within the past 12 months

Inclusion Criteria:

Exclusion Criteria:

ClinicalTrials.gov Identifier: NCT01281384

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Project 1C:
Computed Tomographic Coronary Angiography for Heart Failure Patients (CTA-HF)

Principal research questions

The proposed randomized controlled trial (RCT) will evaluate the clinical utility of computed tomographic coronary angiography (CTA) and investigate its potential benefit on resource utilization and health economics in patients with progressive or newly diagnosed heart failure (HF) of unknown etiology (i.e. ischemic versus non-ischemic) or in whom the definition of coronary anatomy is required for diagnosis and management. The experimental algorithm will be compared to invasive coronary angiography (ICA).

The primary objective is to understand the role of CTA in patients with HF of unknown etiology. We propose a prospective study of 250 patients to examine the potential impact of CTA (compared to ICA) on resource utilization and health care costs in patients with HF with unknown CAD status. Secondary objectives are to: compare CCE, QoL and MACE in the CTA and ICA arms. Radiation exposure and safety in both groups will also be assessed.

All HF patients requiring investigation to determine the etiology of HF (ischemic versus non-ischemic) will be screened for the study.

Patients will be randomized to the investigation arm (CTA) or ICA. Patients will be stratified according to recruitment site and pre-test probability for obstructive CAD. A stratified block (varying sizes) randomization scheme will be used. Within each strata, patients will be randomized with varying block sizes into the two study groups. A central randomization scheme (envelope), which will ensure concealment, will be used and the local research co-ordinator will perform patient assignments.

The proposed trial is a multicentre randomized controlled trial of 250 patients. In addition, a retrospective review of the current CTA and ICA databases at the University of Ottawa Heart Institute will be conducted to identify an additional cohort of patients (200-400) where the imaging modality decision has already been made. These patients are not eligible for randomization, but will be entered into a registry.

Inclusion Criteria

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.

Exclusion Criteria

Clinical Trials.gov Identifier :NCT01283659

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New Initiatives: Bio-AIMI-HF
The Role of Biomarkers in Optimizing Imaging Directed Management in Ischemic Heart Failure

Bio-AIMI-HF is designed as a novel proof of concept cohort study, built upon the existing IMAGE-HF framework, that proposes to evaluate the ability of novel biomarkers to identify candidates with ischemic HF who will benefit from revascularization.

Project Objectives

Determine: i)if cardiac biomarkers with proven potential can predict outcome benefits from revascularization in patients with ischemic HF undergoing an image-guided management strategy ii) optimal thresholds for each targeted biomarker for predicting outcomes

Exploratory objectives:

i)if combined biomarkers accurately predict outcomes; ii) relationships between biomarkers and imaging parameters (remodelling, fibrosis, hibernation, ischemia).

Study Population

Patients presenting with clinical HF or severe LV dysfunction who require definition of ischemia, viability or scar and meet the inclusion/exclusion criteria.

Inclusion/Exclusion Criteria per Project 1A - AIMI-HF

Primary Outcomes

The occurrence of the composite clinical endpoint (CCE) at 2 years.

Secondary Outcomes

Recurrent events; components of the CCE; LV EF; NYHA class; CCS angina class; QoL questionnaire scores [(Minnesota (MLWHFQ) and EQ-5D].Cost data will be captured and if results are positive cost analysis will be undertaken in the future.

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Project 2A:
Canadian Cardiomyopathy Registry for Device therapy (CanCARD-MR)

Device therapy is an important advance in the care of patients with acquired heart disease. In specific cohorts these devices appear to significantly reduce the risk of SCD and HF progression. However, our ability to identify ideal candidates is poor and a significant number of patients continue to present with malignant arrhythmias and HF events despite not meeting current device indications. From preliminary studies DE MRI imaging appears to be one of the more valuable predictors of response to device therapy and holds substantial promise for patients with both ischemic and non-ischemic cardiomyopathy. Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

Hypotheses:

Our global hypothesis is that delayed enhancement MRI (DE-MRI) derived measures of myocardial scar can identify patients most likely to benefit from device therapy irrespective of cardiomyopathy etiology. Determination of signal enhancement heterogeneity (SEH) is hypothesized to predict future arrhythmic events in both ischemic and non-ischemic patterns of mature injury. Determination of transmural signal enhancement (TSE) is hypothesized to predict non-response to CRT in both ischemic and non-ischemic cardiomyopathy.

We have designed a multi-centre prospective cohort registry of consecutive patients clinically referred for primary prevention ICD with our without CRT. A total of 500 patients will be enrolled into the registry over a period of 4 years. All patients will be followed for clinical events for at least 12 months following the date of device implantation. Each patient will have cardiac MRI chosen as the primary diagnostic test to quantitatively assess the ejection fraction. In those where quantitative testing has already been performed without the use of a DE-MRI evaluation, and its performance is not felt to be clinically indicated, the cardiac MRI will be performed as a research-funded study.

Patient Population & Recruitment

Patients referred for or being considered for primary prevention ICD, with or without CRT, will be recruited from the Electrophysiology services at each enrolling site.

Inclusion Criteria:

Exclusion Criteria:

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