Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01288560
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2010-05-19
Brief Title:
IMAGE-HF Project I-A Cardiac Imaging in Ischemic Heart Failure AIMI-HF
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIMI-HF
Brief Summary:
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
PRIMARY OBJECTIVES 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 questions asked by the physicians is there ischemia andor viability in agreement with their local practices for standard and alternative imaging
SECONDARY OBJECTIVES
1 To evaluate the effect of imaging modalities within and between the imaging subgroups advanced CMR and PET PET MRI and standard SPECT on the primary and secondary outcomes in patients being evaluated either for viability andor ischemia
2 To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia
3 To compare the effect of HF imaging strategies on
1 The incidence of revascularization procedures PCI CABG none and the interaction of the imaging strategy and types of revascularization on outcomes
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 eg BNP RDW hs-cTnT hs-CRP ST2
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 eg PIIINP OPN
9 Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
10 All-cause mortality
PRIMARY OBJECTIVES 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 questions asked by the physicians is there ischemia andor viability in agreement with their local practices for standard and alternative imaging
SECONDARY OBJECTIVES
1 To evaluate the effect of imaging modalities within and between the imaging subgroups advanced CMR and PET PET MRI and standard SPECT on the primary and secondary outcomes in patients being evaluated either for viability andor ischemia
2 To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia
3 To compare the effect of HF imaging strategies on
1 The incidence of revascularization procedures PCI CABG none and the interaction of the imaging strategy and types of revascularization on outcomes
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 eg BNP RDW hs-cTnT hs-CRP ST2
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 eg PIIINP OPN
9 Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
10 All-cause mortality
Detailed Description:
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 international team grant IMAGE-HF Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure involving 3 parallel 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 advanced 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 advanced 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 eg 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 eg BNP RDW hs-cTnT hs-CRP f is economically attractive in patients with HF due to IHD with LVEF45 g reduced event rates of each components of composite endpoint h all-cause mortality
ii In patients with HF due to IHD with LVEF 45 a HF management algorithm that applies PET or one that applies MRI achieves a better primary composite clinical endpoint CCE and secondary outcomes compared to one that applies standard of care in patients assessed for ischemia andor in patients assessed for viability
iii 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 compared to one that applies CMR in patients assessed for ischemia andor in patients assessed for viability
iii Renal function impairment is a known independent predictor of cardiovascular events in HF Renal function may influence revascularization decisions and its evolution could be modified by revascularization 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 or 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 PETCT 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 as best as possible a balanced recruitment for each modality registry
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 international team grant IMAGE-HF Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure involving 3 parallel 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 advanced 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 advanced 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 eg 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 eg BNP RDW hs-cTnT hs-CRP f is economically attractive in patients with HF due to IHD with LVEF45 g reduced event rates of each components of composite endpoint h all-cause mortality
ii In patients with HF due to IHD with LVEF 45 a HF management algorithm that applies PET or one that applies MRI achieves a better primary composite clinical endpoint CCE and secondary outcomes compared to one that applies standard of care in patients assessed for ischemia andor in patients assessed for viability
iii 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 compared to one that applies CMR in patients assessed for ischemia andor in patients assessed for viability
iii Renal function impairment is a known independent predictor of cardiovascular events in HF Renal function may influence revascularization decisions and its evolution could be modified by revascularization 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 or 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 PETCT 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 as best as possible a balanced recruitment for each modality registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIF-99470 | OTHER | Canadian Institutes of Health Research | None |