IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)

Summary

Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting.

PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac 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.

SECONDARY OBJECTIVES:

1. To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia.
2. To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.
3. To compare the effect of HF imaging strategies on:

1. The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes
2. LV remodeling: LV volumes, LVEF,
3. HF symptoms, NYHA class
4. QOL (MLHFQ, the EQ5D)
5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)
6. Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
7. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.
8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).
9. Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
10. All-cause mortality

Conditions

• Heart Failure
• Coronary Artery Disease
• Ischemic Cardiomyopathy

Interventions

OTHER

Advanced cardiac imaging

OTHER

Standard Cardiac Imaging

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• The Finnish Funding Agency for Technology and Innovation (TEKES)

  collaborator OTHER_GOV

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Rob S Beanlands, MD, FRCP C · Ottawa Heart Institute Research Corporation

• Eileen O'Meara, MD · Montreal Heart Institute

• Lisa Mielniczuk, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2020-10-31

Completion

2022-10-04

Countries

• United States
• Argentina
• Brazil
• Canada
• Finland

Study Locations