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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Ottawa Heart Institute Research Corporation
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
ClinicalTrials.gov Identifier:
NCT01288560
First received: May 19, 2010
Last updated: August 14, 2015
Last verified: August 2015
  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, 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 Intervention Phase
Heart Failure
Coronary Artery Disease
Ischemic Cardiomyopathy
Non-ischemic Cardiomyopathy
Other: Advanced cardiac imaging
Other: Standard Cardiac Imaging
Phase 4

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)

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • The time to event of the composite clinical endpoint. [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]

    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:
  • Change in Left ventricular ejection fraction, NYHA symptom class, Quality of Life and related resource utilization [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1511
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: September 2016 (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:
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288560

Contacts
Contact: Linda M. Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States
Contact: Marcelo DiCarli, MD         
Argentina
Diagnostico Maipu por Imagenes Recruiting
Buenos Aires, Argentina
Contact: Roxanna Campisi, MD         
Diagnostico Medico Orono Recruiting
Rosario, Argentina
Contact: Maria Cecilia Ziadi, MD         
Brazil
Quanta Diagnóstico e Terapia Recruiting
Curitiba, Brazil
Contact: Joao Vitola         
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, British Columbia
Providence Health Recruiting
Vancouver, British Columbia, Canada
Contact: Jonathan Leipsic, MD         
Canada, Manitoba
University of Manitoba 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 Suspended
London, Ontario, Canada
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Linda M Garrard, RN, BScN    613-761-4192    lgarrard@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         
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         
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         
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 Suspended
Sherbrooke, Quebec, Canada
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         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
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
  More Information

Publications:
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
Study First Received: May 19, 2010
Last Updated: August 14, 2015
Health Authority: Canada: Health Canada

Keywords provided by 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 comaprative effectiveness randomized clinical trial

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

ClinicalTrials.gov processed this record on August 27, 2015