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

NCT01283659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2019-11-21

No results posted yet for this study

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

Interventions

OTHER

Standard Imaging

OTHER

Advanced Imaging

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Finnish Funding Agency for Technology and Innovation (TEKES)

    collaborator OTHER_GOV

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Rob SB Beanlands, MD, FRCP C · University of OttawaHeart Institute

  • Benjamin Chow, MD, FRCP C · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Canada
  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283659 on ClinicalTrials.gov