IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)
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Purpose
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, myocardial infarction (MI), arrest and cardiac re-hospitalization (worsening heart failure (WHF), acute coronary syndrome (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 will compare the effect of HF imaging strategies on the incidence of revascularization procedures (percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG); left ventricular (LV) remodeling; HF symptoms;Quality of Life (QoL), serum prognostic markers in HF (e.g. brain natriuretic peptide (BNP),red blood cell distribution width (RDW);cost and safety.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Coronary Artery Disease Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy |
Other: Advanced cardiac imaging Other: Standard Cardiac Imaging |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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) |
- The time to occurrence of the first composite clinical endpoint. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 1261 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Other: Advanced cardiac imaging
Other Names:
|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Age > 18 years
And
- 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.
And
3a. LV dysfunction most likely attributable to ischemic heart disease with ejection fraction (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
3b. 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 recommended management (e.g. severe Chronic Obstructive Pulmonary Disease (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 valve surgery
- Pregnancy, breast feeding
- Potential for non-compliance to tests involved in this protocol
- Incapacity to provide informed consent
Contacts and Locations| Contact: Linda M. Garrard, RN, BScN | 613-761-4192 | lgarrard@ottawaheart.ca |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Matthias Friedrich, md | |
| Principal Investigator: Matthias Friedrich, MD | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Ian Paterson, MD | |
| Principal Investigator: Ian Paterson, MD | |
| Canada, Manitoba | |
| University of Manitoba | Not yet recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact: Malek Kass, MD | |
| Sub-Investigator: Malek Kass, MD | |
| Sub-Investigator: James Tan, MD | |
| Canada, Nova Scotia | |
| Dalhousie University | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Miroslaw Rajda, MD Miroslaw.Rajda@cdha.nshealth.ca | |
| Principal Investigator: Miroslaw Rajda, MD | |
| Sub-Investigator: James Clarke, MD | |
| Canada, Ontario | |
| McMaster University | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Vikas Tandon vikas.tandon1@gmail.com | |
| Principal Investigator: Vikas Tandon, MD | |
| Sub-Investigator: Karen Gulenchyn, MD | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Contact: Malcolm Arnold, MD | |
| Principal Investigator: Malcolm Arnold, MD | |
| Sub-Investigator: Gerald Wisenberg, MD | |
| Sub-Investigator: James White, MD | |
| University of Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Contact: Linda M Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca | |
| Contact: Cathy Kelly, RN 613-761-4809 ckelly@ottawaheart.ca | |
| Sub-Investigator: Rob S. Beanlands, MD, FRCP C | |
| Principal Investigator: Lisa Mielniczuk, MD, FRCP C | |
| Sub-Investigator: George A Wells, PhD | |
| Sub-Investigator: Robert A. deKemp, PhD | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Graham Wright, MD (416)480-6869 gawright@sri.utoronto.ca | |
| Principal Investigator: Graham Wright, MD | |
| Principal Investigator: Kim Connelly, MD | |
| Sub-Investigator: Charles Cunningham Cunningham, MD | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Kim Connelly, MD 14168645201 connellyk@smh.ca | |
| Principal Investigator: Kim Connelly, MD | |
| Sub-Investigator: Michael Freeman, MD | |
| Sub-Investigator: Howard Leong-Poi, MD | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Eileen O'Meara, MD | |
| Principal Investigator: Eileen O'Meara, MD | |
| Sub-Investigator: Jean-Claude Tardif, MD | |
| University of Laval | Recruiting |
| Quebec City, Quebec, Canada | |
| Contact: Philippe Pibarot, MD | |
| Principal Investigator: Philippe Pibarot, MD | |
| Université de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada | |
| Contact: Eric Turcotte, MD | |
| Principal Investigator: Eric Turcotte, MD | |
| Sub-Investigator: Serge Lepage, MD | |
| Sub-Investigator: Paul Pharand, MD | |
| Finland | |
| Helsinki University Central Hospital, | Recruiting |
| Helsinki, Finland | |
| Contact: Mika Laine, MD 358 405 245735 Mika.Laine@hus.fi | |
| Principal Investigator: Mika Laine, MD | |
| University of Kuopio | Recruiting |
| Kuopio, Finland | |
| Contact: Juha Hartikainen, MD 044-711 3945 Juha.Hartikainen@kuh.fi | |
| Principal Investigator: Juha Hartikainen, MD | |
| Sub-Investigator: Satu Karkkainen, M D | |
| University of Turku | Recruiting |
| Turku, Finland | |
| Contact: Juhani Knuuti, MD | |
| Principal Investigator: Juhani Knuuti, MD | |
| Sub-Investigator: Heikki Ukkonen, MD | |
| Sub-Investigator: Seppo Yla-Herttuala, MD | |
| Study Director: | Rob S Beanlands, MD, FRCP C | University of Ottawa Heart Institute |
| Principal Investigator: | Eileen O'Meara, MD | Montreal Heart Institute |
| Principal Investigator: | Lisa Mielniczuk, MD | University of Ottawa Heart Institute |
More Information
No publications provided
| Responsible Party: | Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01288560 History of Changes |
| Other Study ID Numbers: | Project I-A, CIF-99470 |
| Study First Received: | May 19, 2010 |
| Last Updated: | March 22, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Ottawa Heart Institute:
|
medical imaging heart failure morbidity and mortality PET/CT,CMR,SPECT |
knowledge translation cost effectiveness quality of life |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Failure Ischemia Cardiomyopathies |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013