title: Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01288560.
authors.affiliation: Montreal Heart Institute, Montréal, QC, Canada.
authors.forename: Eileen
authors.initials: E
authors.lastname: O'Meara
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Mielniczuk
authors.forename: George A
authors.initials: GA
authors.lastname: Wells
authors.forename: Robert A
authors.initials: RA
authors.lastname: deKemp
authors.forename: Ran
authors.initials: R
authors.lastname: Klein
authors.forename: Doug
authors.initials: D
authors.lastname: Coyle
authors.forename: Brian
authors.initials: B
authors.lastname: Mc Ardle
authors.forename: Ian
authors.initials: I
authors.lastname: Paterson
authors.forename: James A
authors.initials: JA
authors.lastname: White
authors.forename: Malcolm
authors.initials: M
authors.lastname: Arnold
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Friedrich
authors.forename: Eric
authors.initials: E
authors.lastname: Larose
authors.forename: Alexander
authors.initials: A
authors.lastname: Dick
authors.forename: Benjamin
authors.initials: B
authors.lastname: Chow
authors.forename: Carole
authors.initials: C
authors.lastname: Dennie
authors.forename: Haissam
authors.initials: H
authors.lastname: Haddad
authors.forename: Terrence
authors.initials: T
authors.lastname: Ruddy
authors.forename: Heikki
authors.initials: H
authors.lastname: Ukkonen
authors.forename: Gerald
authors.initials: G
authors.lastname: Wisenberg
authors.forename: Bernard
authors.initials: B
authors.lastname: Cantin
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.forename: Michael
authors.initials: M
authors.lastname: Freeman
authors.forename: Eric
authors.initials: E
authors.lastname: Turcotte
authors.forename: Kim
authors.initials: K
authors.lastname: Connelly
authors.forename: James
authors.initials: J
authors.lastname: Clarke
authors.forename: Kathryn
authors.initials: K
authors.lastname: Williams
authors.forename: Normand
authors.initials: N
authors.lastname: Racine
authors.forename: Linda
authors.initials: L
authors.lastname: Garrard
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Tardif
authors.forename: Jean
authors.initials: J
authors.lastname: DaSilva
authors.forename: Juhani
authors.initials: J
authors.lastname: Knuuti
authors.forename: Rob
authors.initials: R
authors.lastname: Beanlands
mesh_terms: D000465:Algorithms; D002170:Canada; D002985:Clinical Protocols; D003952:Diagnostic Imaging / Q000379:methods*; D006323:Heart Arrest / Q000209:etiology; D006333:Heart Failure / Q000175:diagnosis* / Q000209:etiology / Q000401:mortality / Q000628:therapy; D006801:Humans; D008279:Magnetic Resonance Imaging; D009203:Myocardial Infarction / Q000209:etiology; D017202:Myocardial Ischemia / Q000150:complications / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy; D010359:Patient Readmission; D018579:Patient Selection; D049268:Positron-Emission Tomography; D011237:Predictive Value of Tests; D011379:Prognosis; D012042:Registries; D012107:Research Design; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon