IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF) (AIMI-HF)
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|ClinicalTrials.gov Identifier: NCT01288560|
Recruitment Status : Active, not recruiting
First Posted : February 2, 2011
Last Update Posted : November 21, 2019
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
- The incidence of revascularization procedures (PCI, CABG)
- LV remodeling: LV volumes, LVEF
- HF symptoms, NYHA class
- QOL (MLHFQ, the EQ5D)
- The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)
- Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
- The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.
- The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Coronary Artery Disease Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy||Other: Advanced cardiac imaging Other: Standard Cardiac Imaging||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 2021|
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)
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).
Other: Standard Cardiac Imaging
Other Name: SPECT
- The time to event of the composite clinical endpoint. [ Time Frame: 3, 12 and 24 months ]
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.
- Change in Left ventricular ejection fraction, NYHA symptom class, Quality of Life and related resource utilization [ Time Frame: 3, 12 and 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288560
|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|