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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 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, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01288560
First received: May 19, 2010
Last updated: June 15, 2015
Last verified: June 2015

May 19, 2010
June 15, 2015
January 2011
September 2016   (final data collection date for primary outcome measure)
The time to event of the composite clinical endpoint. [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]

For the primary analysis, the time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization

(WHF, ACS, arrhythmia) will be compared between the advanced modality (PET or CMR) to an approach with standard care using SPECT imaging using survival analysis. Kaplan-Meier survival curves of the primary endpoint will be compared between the advanced and standard modalities with the log-rank test. In addition for the primary hypothesis, a SPECT registry will be considered in order to make the allocation between the advanced and standard modalities 1:1.

The time to occurrence of the first composite clinical endpoint. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01288560 on ClinicalTrials.gov Archive Site
Change in Left ventricular ejection fraction, NYHA symptom class, Quality of Life and related resource utilization [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
For the secondary outcomes PCI, CABG, HF symptoms and NYHA class, chi-square tests will be used to compare the advanced and standard imaging technologies; logistic regression analysis will be used for adjusting any pertinent baseline differences identified. For the secondary outcomes LVEF, MLHFQ and EQ5D, analysis of variance will be used to compare trends over time between the advanced and standard technologies. Analysis of covariance will be used for adjusting any pertinent baseline differences identified.
  • 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 ]
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, 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 of AIMI-HF 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)
  5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)
  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).

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 of AIMI-HF:

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

Secondary Hypotheses of AIMI-HF:

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 LV remodeling (including favorable evolution of serum markers associated with LV remodeling e.g. PIIINP, OPN) c) better HF and angina symptom reduction, d) better QoL, measured using MLHFQ and EQ5D, e) more favorable evolution of selected serum markers of prognosis in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP) and f) is economically attractive in patients with HF due to IHD with LVEF<45%.

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 (CCE) and secondary outcomes (revascularizations, remodeling, QoL, Cost efficiency) compared to one that applies CMR.

iii) Renal function impairment is a known independent predictor of cardiovascular events in HF. Renal function may influence revascularisation decisions and its evolution could be modified by revascularisation procedures.

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.

Interventional
Phase 4
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1511
June 2017
September 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age >18 years
  • 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
  • LV dysfunction most likely attributable to ischemic heart disease with 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

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:

  • Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization.
  • < 4 weeks post ST segment elevation myocardial infarction (STEMI)
  • Already identified as not suitable for revascularization;
  • Emergency revascularization indicated
  • Severe valvular heart disease requiring surgery
  • Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR <30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR <30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available
  • Pregnancy
  • Potential for non compliance to tests involved in this protocol
  • Incapacity to provide informed consent
Both
18 Years and older
No
Contact: Linda M. Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca
United States,   Argentina,   Brazil,   Canada,   Finland
 
NCT01288560
Project I-A, CIF-99470
Yes
Rob Beanlands, Ottawa Heart Institute Research Corporation
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
June 2015

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