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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ottawa Heart Institute Research Corporation
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Rob Beanlands, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01288560
First received: May 19, 2010
Last updated: August 29, 2014
Last verified: August 2014

May 19, 2010
August 29, 2014
January 2011
September 2015   (final data collection date for primary outcome measure)
The time to occurrence of the first composite clinical endpoint. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01288560 on ClinicalTrials.gov Archive Site
  • Change in LVEF as measured by echocardiography [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • Change in NYHA symptom class based on telephone interview and/or clinical assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • QoL measures using validated questionnaires [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The time to occurrence of the first composite clinical endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in NYHA symptom class based on telephone interview and/or clinical [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in NYHA symptom class based on telephone interview and/or clinical [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in NYHA symptom class based on telephone interview and/or clinical [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in NYHA symptom class based on telephone interview and/or clinical [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • QoL measures using validated questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • QoL measures using validated questionnaires [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • QoL measures using validated questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • QoL measures using validated questionnaires [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The time to occurrence of the first composite clinical endpoint. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The time to occurrence of the first composite clinical endpoint. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • The time to occurrence of the first composite clinical endpoint. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)
Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Project I-A of Imaging Modalities to Assist With Guiding Therapy and the Evaluation of Patients With Heart Failure (IMAGE-HF)

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. The OVERALL OBJECTIVES of the IMAGE-HF trial are 1) to determine the impact of emerging imaging strategies, on relevant clinical outcomes and decision making in patients with HF; 2) to establish standardization quality assurance (QA) measures and central databases in order to achieve reliable outcome driven research; 3) to apply this as a platform for evaluation of new and emerging imaging biomarkers in HF.

Project I-A: The PRIMARY OBJECTIVE OF AIMI-HF is to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, myocardial infarction (MI), arrest and cardiac re-hospitalization (worsening heart failure (WHF), acute coronary syndrome (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 will compare the effect of HF imaging strategies on the incidence of revascularization procedures (percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG); left ventricular (LV) remodeling; HF symptoms;Quality of Life (QoL), serum prognostic markers in HF (e.g. brain natriuretic peptide (BNP),red blood cell distribution width (RDW);cost and safety.

Among patients with coronary artery disease and HF, mortality rates range from 10-60% at 1 year. Many trials have demonstrated benefit of revascularization in patients with ischemic heart disease (IHD) and LV dysfunction. Some criteria, such as severe angina or left main coronary artery stenosis may indicate the need for surgical therapy for HF patients; however, a large number of patients fall into a gray zone without clear evidence for benefit from surgical intervention. The need remains for approaches that can help better define and select the HF patients most likely to benefit from revascularization; which could be either surgical or percutaneous intervention.

Increasingly over the past three decades, information describing cardiac structure, perfusion, hemodynamics, and metabolism obtained from noninvasive cardiac imaging studies has been used to guide management decisions for patients with HF.

AIMI-HF is part of a large Canadian team grant IMAGE-HF (Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure) involving 3 parallel randomized trials addressing the role of imaging in HF patients according to HF etiology.

Primary Hypothesis:

In patients with HF due to IHD with left ventricular ejection fraction (LVEF) ≤ 45%, a management algorithm that applies alternative imaging strategies (PET or CMR) achieves a better clinical outcome measured as the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) than an approach with standard care using SPECT imaging.

Secondary Hypotheses:

i) Compared to standard care, in patients with HF due to IHD with LVEF ≤ 45% a management algorithm that applies alternative imaging modalities (PET or CMR) achieves: a) more efficient use of revascularization procedures with similar complication rates than standard care imaging strategies; b) better HF and angina symptom reduction; c) better quality of life (QoL), measured using MLHFQ and EQ5D; and d) is cost-effective.

ii) In patients with HF due to IHD with LVEF ≤ 45%, a HF management algorithm that applies PET achieves a better primary (composite clinical endpoint) and secondary outcomes (revascularizations, remodeling, QoL, cost effectiveness) compared to one that applies CMR.

Primary objective:

The primary objective of AIMI-HF is 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 HF due to an ischemic heart disease (IHD) etiology of LV dysfunction 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:

To compare the effect of HF imaging strategies on

  1. The incidence of revascularization procedures (PCI, CABG)
  2. LVEF
  3. HF symptoms, New York Heart Association (NYHA) class
  4. QOL (MLHFQ, the EQ5D)
  5. Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
  6. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.

Study design The AIMI-HF is a randomized controlled trial to compare the effectiveness of HF imaging strategies in patients with HF due to IHD. Patients enrolled will have LV systolic dysfunction due to IHD where evaluation of ischemia and viability is relevant. Patients will be allocated in a concealed fashion to standard (SPECT) versus advanced (PET or CMR) imaging. In addition, a registry will be maintained of patients undergoing standard or advanced imaging based on clinical decisions.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Heart Failure
  • Coronary Artery Disease
  • Ischemic Cardiomyopathy
  • Non-ischemic Cardiomyopathy
  • Other: Advanced cardiac imaging
    Other Names:
    • Cardiac PET/CT Imaging
    • Cardiac magnetic Resonance Imaging
  • Other: Standard Cardiac Imaging
    Other Name: SPECT
  • Active Comparator: Advanced cardiac imaging (PET/CT or CMR)
    Patients will undergo cardiac imaging as evaluation of heart failure using 1 of the following alternate/advanced imaging modalities: Positron Emission Tomography (PET/CT), Cardiac Magnetic Resonance (CMR), computed tomography angiogram (CTA)
    Intervention: Other: Advanced cardiac imaging
  • Active Comparator: Standard cardiac imaging (SPECT)
    Patients will undergo standard cardiac imaging procedures for evaluation of heart failure such as single photon emission computed tomography (SPECT).
    Intervention: Other: Standard Cardiac Imaging
O'Meara E, Mielniczuk LM, Wells GA, deKemp RA, Klein R, Coyle D, Mc Ardle B, Paterson I, White JA, Arnold M, Friedrich MG, Larose E, Dick A, Chow B, Dennie C, Haddad H, Ruddy T, Ukkonen H, Wisenberg G, Cantin B, Pibarot P, Freeman M, Turcotte E, Connelly K, Clarke J, Williams K, Racine N, Garrard L, Tardif JC, DaSilva J, Knuuti J, Beanlands R; IMAGE HF investigators. Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial. Trials. 2013 Jul 16;14:218. doi: 10.1186/1745-6215-14-218.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1261
June 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Age > 18 years

    And

  2. Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging.

And

3a. LV dysfunction most likely attributable to ischemic heart disease with ejection fraction (EF) <45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months.

OR

3b. LV dysfunction most likely attributable to ischemic heart disease with EF ≤ 30% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months.

Exclusion criteria:

  1. Severe medical conditions that significantly affect the patient's recommended management (e.g. severe Chronic Obstructive Pulmonary Disease (COPD), active metastatic malignancy), and would preclude revascularization.
  2. < 4 weeks post-ST segment elevation myocardial infarction (STEMI)
  3. Already identified as not suitable for revascularization
  4. Emergency revascularization indicated
  5. Severe valvular heart disease requiring valve surgery
  6. Pregnancy, breast feeding
  7. Potential for non-compliance to tests involved in this protocol
  8. Incapacity to provide informed consent
Both
18 Years and older
No
Contact: Linda M. Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca
Canada,   Finland
 
NCT01288560
Project I-A, CIF-99470
Yes
Rob Beanlands, University of Ottawa Heart Institute
Ottawa Heart Institute Research Corporation
  • Canadian Institutes of Health Research (CIHR)
  • The Finnish Funding Agency for Technology and Innovation (TEKES)
Study Director: Rob S Beanlands, MD, FRCP C Ottawa Heart Institute Research Corporation
Principal Investigator: Eileen O'Meara, MD Montreal Heart Institute
Principal Investigator: Lisa Mielniczuk, MD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP