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Trial record 88 of 245 for:    "ottawa heart institute"

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 : December 24, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Rob Beanlands, Ottawa Heart Institute Research Corporation

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. 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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2011
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Cardiac PET/CT Imaging
  • Cardiac magnetic Resonance 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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States
Argentina
Diagnostico Maipu por Imagenes
Buenos Aires, Argentina
Diagnostico Medico Orono
Rosario, Argentina
Brazil
Quanta Diagnóstico e Terapia
Curitiba, Brazil
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Providence Health
Vancouver, British Columbia, Canada
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
University of Laval
Quebec City, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Finland
Helsinki University Central Hospital,
Helsinki, Finland
University of Kuopio
Kuopio, Finland
University of Turku
Turku, Finland
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
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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

Publications:
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Responsible Party: Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01288560     History of Changes
Other Study ID Numbers: Project I-A
CIF-99470 ( Other Identifier: Canadian Institutes of Health Research )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rob Beanlands, Ottawa Heart Institute Research Corporation:
medical imaging
heart failure
morbidity and mortality
PET/CT,CMR,SPECT, echo, coronary angiography
knowledge translation
cost effectiveness
quality of life
prospective comparative effectiveness randomized clinical trial

Additional relevant MeSH terms:
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Heart Failure
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases