IMAGE-HF Project I-C: Computed Tomographic Coronary Angiography for Heart Failure Patients

NCT01283659 | Completed DMC

• 2 other identifiers: Project I-CCIF-99470
• Study Type: interventional
• Target: 253
• Locations: 2 countries
• Sites: 15

Brief Summary

Background: The prevalence of heart failure (HF) is rapidly rising in industrialized and developing countries. Though invasive coronary angiography (ICA) remains the gold standard for anatomical assessment of coronary arteries and luminal stenoses in these patients, alternatives have been sought. Computed tomographic coronary angiography (CTA) has emerged as an accurate non-invasive diagnostic tool for CAD and has been demonstrated to have prognostic value. Whether or not CTA can be used in patients with HF for diagnosis and to guide patient investigations and management is unknown. Acknowledging the aging population in industrialized counties, the increasing burden of healthcare and growing prevalence of HF, there is a need to identify non-invasive diagnostic tests that are cost-effective, readily available, safe and of sufficient accuracy to risk stratify patients and guide investigations and management. Methods: The proposed randomized controlled trial (RCT) will evaluate the clinical utility of computed tomographic coronary angiography (CTA) and investigate its potential benefit on resource utilization and health economics in patients with progressive or newly diagnosed heart failure (HF) of unknown etiology (i.e. ischemic versus non- ischemic) or in whom the definition of coronary anatomy is required for diagnosis and management. The experimental algorithm will be compared to invasive coronary angiography (ICA) Analysis of composite clinical events and major adverse cardiac events will be performed to determine the impact of these strategies upon patient outcomes. Accuracy of CTA in detection of coronary anatomy and obstruction will be assessed in patients undergoing 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.

Conditions

Heart Failure

Keywords

computed tomographic angiography; coronary angiogram; cost effectiveness; QoL; Heart failure; diagnostic accuracy; prospective comparative effectiveness randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Resource Utilization

  Primary Outcome Measure: Resource Utilization: will be measured as detailed in Appendix A. Cost: the incremental cost of the diagnostic strategy using CTA will be the primary endpoint and will be estimated through regression methods.

  3 and 12 months

Secondary Outcomes (2)

• Clinical Endpoints

  3 and 12 months

• CTA Accuracy

  Baseline

Study Arms (2)

Standard imaging (coronary angiography)

ACTIVE COMPARATOR

Subjects will undergo a coronary angiogram as planned by their attending doctor

Other: Standard Imaging

Advanced imaging (CTA)

ACTIVE COMPARATOR

Subjects will undergo a CTA scan first. Based on the CTA results, subjects may or may not proceed to coronary angiography. CTA results will be reviewed by the attending physician.

Other: Advanced Imaging

Interventions

Standard Imaging OTHER

Also known as: Coronary Angiography

Standard imaging (coronary angiography)

Advanced Imaging OTHER

Also known as: Coronary Computed Tomographic Angiography

Advanced imaging (CTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a documented history of left ventricular dysfunction (LVEF \<50%)
• a documented history of Class ll-lV heart failure symptoms, in the preceding 12 months prior to enrollment, in whom the diagnosis of CAD is uncertain or the definition of coronary anatomy is required for diagnosis and management.

You may not qualify if:

• Age \< 18 years or lack of consent,
• Renal Insufficiency (GFR \< 45 ml/min);
• Allergy to intravenous contrast agents;
• Contraindication to radiation exposure (e.g. pregnancy);
• Uncontrolled HR at time of scan (as per local clinical routine)
• History of revascularization (CABG or PCI);
• Atrial fibrillation, frequent atrial or ventricular ectopy (\> 1 / minute);
• Unable to perform 20 second breath-hold;
• CTA or ICA within the preceding 12 months

Sponsors & Collaborators

• The Finnish Funding Agency for Technology and Innovation (TEKES): collaborator
• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (15)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

University of Laval

Québec, Quebec, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Helsinki University Central Hospital,

Helsinki, Finland

Location

University of Kuopio

Kuopio, Finland

Location

University of Turku

Turku, Finland

Location

Related Publications (3)

• Paterson DI, OMeara E, Chow BJ, Ukkonen H, Beanlands RS. Recent advances in cardiac imaging for patients with heart failure. Curr Opin Cardiol. 2011 Mar;26(2):132-43. doi: 10.1097/HCO.0b013e32834380e7.

  PMID: 21297464 BACKGROUND

• Chow BJ, Green RE, Coyle D, Laine M, Hanninen H, Leskinen H, Rajda M, Larose E, Hartikainen J, Hedman M, Mielniczuk L, O'Meara E, deKemp RA, Klein R, Paterson I, White JA, Yla-Herttuala S, Leber A, Tandon V, Lee T, Al-Hesayen A, Hessian R, Dowsley T, Kass M, Kelly C, Garrard L, Tardif JC, Knuuti J, Beanlands RS, Wells GA; IMAGE-HF Investigators. Computed tomographic coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE HF Project 1-C). Trials. 2013 Dec 26;14:443. doi: 10.1186/1745-6215-14-443.

  PMID: 24369097 BACKGROUND

• Chow BJW, Coyle D, Hossain A, Laine M, Hanninen H, Ukkonen H, Rajda M, Larose E, Hartikainen J, Mielniczuk L, Kass M, Connelly KA, O'Meara E, Garrard L, Bishop H, Small G, Hedman M, Coyle K, Yla-Herttuala S, Knuuti J, Wells GA, Beanlands RS; IMAGE-HF Investigators. Computed tomography coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE-HF 1C). Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1083-1090. doi: 10.1093/ehjci/jeaa109.

  PMID: 32588042 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rob SB Beanlands, MD, FRCP C

  University of OttawaHeart Institute

  STUDY DIRECTOR

• Benjamin Chow, MD, FRCP C

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

FI (3); CA (12)