Open Access Study protocol

Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial

Eileen O’Meara4, Lisa M Mielniczuk12*, George A Wells12, Robert A deKemp12, Ran Klein12, Doug Coyle2, Brian Mc Ardle12, Ian Paterson7, James A White5, Malcolm Arnold5, Matthias G Friedrich4, Eric Larose8, Alexander Dick123, Benjamin Chow123, Carole Dennie123, Haissam Haddad12, Terrence Ruddy12, Heikki Ukkonen6, Gerald Wisenberg5, Bernard Cantin8, Philippe Pibarot8, Michael Freeman9, Eric Turcotte10, Kim Connelly119, James Clarke12, Kathryn Williams12, Normand Racine4, Linda Garrard12, Jean-Claude Tardif4, Jean DaSilva12, Juhani Knuuti6, Rob Beanlands123 and the IMAGE HF investigators

Author Affiliations

1 Division of Cardiology, (including Cardiac Imaging, The National Cardiac PET Centre, The Heart Failure Program, and the Cardiac Research Methods Centre), Department of Medicine, University of Ottawa Heart Institute, 40 Ruskin Ave, Ottawa, ON K1Y 4W7, Canada

2 University of Ottawa, 75 Laurier Avenue East, Ottawa, ON K1N 6N5, Canada

3 Department of Radiology, The Ottawa Hospital, Module S, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada

4 Montreal Heart Institute, 5000 Bélanger Street, Montréal, QC H 1T 1C8, Canada

5 London Health Sciences Centre, 800 Commissioners Road East, PO Box 5010, London, ON N6A 5W9, Canada

6 Turku PET Centre, c/o Turku University Hospital, P.O. Box 5220521, Turku, Finland

7 University of Alberta, 116 St, Edmonton, AB T6G 2R3, Canada

8 Université de Québec, 2325 Rue de l'Université, Québec City, QC, Canada

9 St. Michael's Hospital, 30 Bond St, Toronto, ON M5B 1W8, Canada

10 Université de Sherbrooke, 2500 boul. de l'Université, Sherbrooke, QC J1K 2R1, Canada

11 Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON M4N 3M5, Canada

12 Dalhousie University, 1236 Henry St, Halifax, NS B3H 1B6, Canada

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Trials 2013, 14:218  doi:10.1186/1745-6215-14-218

Published: 16 July 2013

Abstract

Background

Ischemic heart disease (IHD) is the most common cause of heart failure (HF); however, the role of revascularization in these patients is still unclear. Consensus on proper use of cardiac imaging to help determine which candidates should be considered for revascularization has been hindered by the absence of clinical studies that objectively and prospectively compare the prognostic information of each test obtained using both standard and advanced imaging.

Methods/Design

This paper describes the design and methods to be used in the Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) multi-center trial. The primary objective is to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, myocardial infarction (MI), cardiac arrest and re-hospitalization for cardiac causes.

In AIMI-HF, patients with HF of ischemic etiology (n = 1,261) will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (for example, Is there ischemia and/or viability?), in agreement with local practices. Patients will be randomized to either standard (SPECT, Single photon emission computed tomography) imaging modalities for ischemia and/or viability or advanced imaging modalities: cardiac magnetic resonance imaging (CMR) or positron emission tomography (PET). In addition, eligible and consenting patients who could not be randomized, but were allocated to standard or advanced imaging based on clinical decisions, will be included in a registry.

Discussion

AIMI-HF will be the largest randomized trial evaluating the role of standard and advanced imaging modalities in the management of ischemic cardiomyopathy and heart failure. This trial will complement the results of the Surgical Treatment for Ischemic Heart Failure (STICH) viability substudy and the PET and Recovery Following Revascularization (PARR-2) trial. The results will provide policy makers with data to support (or not) further investment in and wider dissemination of alternative ‘advanced’ imaging technologies.

Trial registration

NCT01288560