Open Access Study protocol

Computed tomographic coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE HF Project 1-C)

Benjamin JW Chow123*, Rachel E Green1, Doug Coyle4, Mika Laine5, Helena Hanninen5, Hanna Leskinen6, Miroslav Rajda7, Eric Larose8, Juha Hartikainen9, Marja Hedman9, Lisa Mielniczuk12, Eileen O’Meara10, Robert A deKemp12, Ran Klein1, Ian Paterson11, James A White12, Seppo Yla-Herttuala6, Alex Leber13, Vikas Tandon14, Ting Lee12, Abdul Al-Hesayen1, Renee Hessian12, Taylor Dowsley1, Malek Kass15, Cathy Kelly1, Linda Garrard1, Jean-Claude Tardif10, Juhani Knuuti6, Rob S Beanlands123, George A Wells123 and on behalf of the IMAGE-HF Investigators

Author Affiliations

1 Department of Medicine, Division of Cardiology, (including Cardiac Imaging, The Heart Failure Program, and the Cardiac ResearchMethods Centre), University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada

2 Department of Medicine, University of Ottawa, 75 Laurier Avenue East, Ottawa, ON K1N 6N5, Canada

3 Department of Radiology, University of Ottawa, 75 Laurier Avenue East, Ottawa, ON K1N 6N5, Canada

4 Department of Epidemiology and Community Medicine, University of Ottawa, 75 Laurier Avenue East, Ottawa, ON K1N 6N5, Canada

5 Helsinki University Central Hospital, Stenbäckinkatu 9, PO BOX 100, FI-00029, Helsinki, Finland

6 Turku PET Centre, Turku PET Centre, c/o Turku University Hospital, P.O. Box 5220521, Turku, Finland

7 Dalhousie University, 6299 South Street, PO Box 15000, Halifax NS B3H 4R2, Canada

8 Université de Québec, 2325 Rue de l'Université, Québec City, QC G1V 0B4, Canada

9 Heart Centre Kuopio University Hospital, 2 Puijonlaaksontie, 70211, Kuopio, Finland

10 Montréal Heart Institute, Université de Montréal, 5000 Bélanger Street, Montréal, QC H1T 1C8, Canada

11 University of Alberta, 116 St and 85 Ave, Edmonton, AB T6G 2R3, Canada

12 London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada

13 Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON M4N 3M5, Canada

14 McMaster University, 1280 Main St W, Hamilton, ON L8S 4L8, Canada

15 University of Manitoba, 66 Chancellors Cir, Winnipeg, MB R3T 2N2, Canada

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Trials 2013, 14:443  doi:10.1186/1745-6215-14-443

Published: 26 December 2013

Abstract

Background

The prevalence of heart failure (HF) is rising in industrialized and developing countries. Though invasive coronary angiography (ICA) remains the gold standard for anatomical assessment of coronary artery disease in HF patients, alternatives are being sought. Computed tomographic coronary angiography (CTA) has emerged as an accurate non-invasive diagnostic tool for coronary artery disease (CAD) and has been demonstrated to have prognostic value. Whether or not CTA can be used in HF patients is unknown. Acknowledging the aging population, the growing prevalence of HF and the increasing financial burden of healthcare, we need to identify non-invasive diagnostic tests that are available, safe, accurate and cost-effective.

Methods/Design

The proposed study aims to provide insight into the efficacy of CTA in HF patients. A multicenter randomized controlled trial will enroll 250 HF patients requiring coronary anatomical definition. Enrolled patients will be randomized to either CTA or ICA (n = 125 per group) as the first test to define coronary anatomy. The primary outcomes will be collected to determine downstream resource utilization. Secondary outcomes will include the composite clinical events and major adverse cardiac events. In addition, the accuracy of CTA for detecting coronary anatomy and obstruction will be assessed in patients who subsequently undergo both CTA and ICA. It is expected that CTA will be a more cost-effective strategy for diagnosis: yielding similar outcomes with fewer procedural risks and improved resource utilization.

Trial registration

ClinicalTrials.gov, NCT01283659

Team grant #CIF 99470