IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/26/2018 |
| Start Date: | January 2011 |
| End Date: | June 2020 |
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).
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.
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.
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
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