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

NCT01288560 | Completed

• 2 other identifiers: Project I-ACIF-99470
• Study Type: interventional
• Target: 1,390
• Locations: 5 countries
• Sites: 20

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 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:

1. 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 and/or ischemia.
2. 2.To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.
3. 3.To compare the effect of HF imaging strategies on:
4. 4.The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes
5. 5.LV remodeling: LV volumes, LVEF,
6. 6.HF symptoms, NYHA class
7. 7.QOL (MLHFQ, the EQ5D)
8. 8.The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)
9. 9.Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
10. 10.The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.
11. 11.The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).
12. 12.Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
13. 13.All-cause mortality

Conditions

Heart Failure; Coronary Artery Disease; Ischemic Cardiomyopathy

Keywords

medical imaging; heart failure; morbidity and mortality; PET/CT,CMR,SPECT, echo, coronary angiography; knowledge translation; cost effectiveness; quality of life; prospective comparative effectiveness clinical trial

Outcome Measures

Primary Outcomes (1)

• The time to event of the composite clinical endpoint.

  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 advanced (PET or CMR) vs standard care (SPECT). A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and associated 95 percent confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model.

  From enrolment until date of death or up to 60 months

Secondary Outcomes (14)

• The time to event of the composite clinical endpoint viability cohort.

  From enrolment until date of death or up to 60 months

• The time to event of the composite clinical endpoint ischemia cohort.

  From enrolment until date of death or up to 60 months

• The time to event of the composite clinical endpoint (PET vs MRI).

  From enrolment until date of death or up to 60 months

• Imaging modalities: Comparing PET and MRI vs SPECT modalities and for the components of the composite

  From enrolment until date of death or up to 60 months

• Imaging modalities: Comparing PET vs SPECT modalities and for the components of the composite

  From enrolment until date of death or up to 60 months

Other Outcomes (2)

• Cost-effectiveness economic analysis of advances vs standard modalities

  From enrolment until date of death or up to 60 months

• Safety Analysis between advanced and standard modalities

  From enrolment until date of death or up to 60 months

Study Arms (2)

Advanced cardiac imaging (PET/CT or CMR)

ACTIVE COMPARATOR

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

Standard cardiac imaging (SPECT)

ACTIVE COMPARATOR

Patients will undergo standard cardiac imaging procedures for evaluation of heart failure such as single photon emission computed tomography (SPECT).

Other: Standard Cardiac Imaging

Interventions

Advanced cardiac imaging OTHER

Also known as: Cardiac PET/CT Imaging, Cardiac magnetic Resonance Imaging

Advanced cardiac imaging (PET/CT or CMR)

Standard Cardiac Imaging OTHER

Also known as: SPECT

Standard cardiac imaging (SPECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Finnish Funding Agency for Technology and Innovation (TEKES): collaborator

Study Sites (20)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

Diagnostico Maipu por Imagenes

Buenos Aires, Argentina

Location

Diagnostico Medico Orono

Rosario, Argentina

Location

Quanta Diagnóstico e Terapia

Curitiba, Brazil

Location

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Providence Health

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

University of Laval

Québec, Quebec, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Helsinki University Central Hospital,

Helsinki, Finland

Location

University of Kuopio

Kuopio, Finland

Location

University of Turku

Turku, Finland

Location

Related Publications (3)

• Paterson DI, OMeara E, Chow BJ, Ukkonen H, Beanlands RS. Recent advances in cardiac imaging for patients with heart failure. Curr Opin Cardiol. 2011 Mar;26(2):132-43. doi: 10.1097/HCO.0b013e32834380e7.

  PMID: 21297464 BACKGROUND

• 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.

  PMID: 23866673 BACKGROUND

• Mielniczuk LM, O'Meara E, Wiefels C, Chen L, Garrard L, White J, deKemp RA, Di Carli MF, Larose E, Paterson DI, Ezekowitz J, Kandolin RM, Wright G, Campisi R, Laine MK, Connelly K, Rajda M, Vitola JV, Lepage S, Hartikainen J, Chow B, Tavoosi A, Knuuti J, Wells GA, Beanlands RSB; IMAGE HF Investigators. The Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Trial-IMAGE HF Project 1A. CJC Open. 2025 Jul 16;7(11):1423-1433. doi: 10.1016/j.cjco.2025.06.023. eCollection 2025 Nov.

  PMID: 41425785 DERIVED

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rob S Beanlands, MD, FRCP C

  Ottawa Heart Institute Research Corporation

  STUDY DIRECTOR

• Eileen O'Meara, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Lisa Mielniczuk, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: October 31, 2020
• Study Completion: October 4, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1); FI (3); AR (2); BR (1); CA (13)