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 2014 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, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01288560
First received: May 19, 2010
Last updated: August 29, 2014
Last verified: August 2014
  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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The time to occurrence of the first composite clinical endpoint. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: June 2016
Estimated Primary Completion Date: September 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:
  • 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:

  1. Age > 18 years

    And

  2. 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:

  1. 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.
  2. < 4 weeks post-ST segment elevation myocardial infarction (STEMI)
  3. Already identified as not suitable for revascularization
  4. Emergency revascularization indicated
  5. Severe valvular heart disease requiring valve surgery
  6. Pregnancy, breast feeding
  7. Potential for non-compliance to tests involved in this protocol
  8. 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
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         
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 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         
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

No publications provided by Ottawa Heart Institute Research Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
medical imaging
heart failure
morbidity and mortality
PET/CT,CMR,SPECT
knowledge translation
cost effectiveness
quality of life

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

ClinicalTrials.gov processed this record on September 30, 2014