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

Benjamin J W Chow, Rachel E Green, Doug Coyle, Mika Laine, Helena Hanninen, Hanna Leskinen, Miroslav Rajda, Eric Larose, Juha Hartikainen, Marja Hedman, Lisa Mielniczuk, Eileen O'Meara, Robert A deKemp, Ran Klein, Ian Paterson, James A White, Seppo Yla-Herttuala, Alex Leber, Vikas Tandon, Ting Lee, Abdul Al-Hesayen, Renee Hessian, Taylor Dowsley, Malek Kass, Cathy Kelly, Linda Garrard, Jean-Claude Tardif, Juhani Knuuti, Rob S Beanlands, George A Wells, IMAGE-HF Investigators, Benjamin J W Chow, Rachel E Green, Doug Coyle, Mika Laine, Helena Hanninen, Hanna Leskinen, Miroslav Rajda, Eric Larose, Juha Hartikainen, Marja Hedman, Lisa Mielniczuk, Eileen O'Meara, Robert A deKemp, Ran Klein, Ian Paterson, James A White, Seppo Yla-Herttuala, Alex Leber, Vikas Tandon, Ting Lee, Abdul Al-Hesayen, Renee Hessian, Taylor Dowsley, Malek Kass, Cathy Kelly, Linda Garrard, Jean-Claude Tardif, Juhani Knuuti, Rob S Beanlands, George A Wells, IMAGE-HF Investigators

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.

Figures

Figure 1
Figure 1
IMAGE-HF Project I-C: experimental algorithm to evaluate use of tomographic coronary angiography (CTA) in determination of heart failure (HF) etiology. Figure 1 illustrates the experimental model of this study, in which the ability of CTA to determine etiology of HF will be compared to that of invasive coronary angiography (ICA). All patients exhibiting HF of unknown etiology will be considered; patients with contraindications to CTA will be excluded.
Figure 2
Figure 2
Timeline for IMAGE-HF Project I-C patient follow-up.

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