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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Rob Beanlands, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01283659
First received: January 20, 2011
Last updated: January 9, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Heart Failure Other: Standard Imaging Other: Advanced Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computed Tomographic Coronary Angiography for Heart Failure Patients (CTA -HF) Project I-C 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 Rob Beanlands, Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Resource Utilization [ Time Frame: 3 and 12 months ]
    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.


Secondary Outcome Measures:
  • Clinical Endpoints [ Time Frame: 3 and 12 months ]
    CCE, LV Function, QoL, and Safety: will measured.

  • CTA Accuracy [ Time Frame: Baseline ]
    CTA Accuracy: To address one of the secondary hypotheses: the accuracy in the cohort of patients with CTA undergoing ICA (~ n=100) diagnostic test characteristics (sensitivity, specificity, predictive values and likelihood ratios) will be determined and reported with 95% confidence intervals (CI).


Enrollment: 253
Study Start Date: February 2011
Estimated Study Completion Date: June 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard imaging (coronary angiography)
Subjects will undergo a coronary angiogram as planned by their attending doctor
Other: Standard Imaging
Other Name: Coronary Angiography
Active Comparator: Advanced imaging (CTA)
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
Other Name: Coronary Computed Tomographic Angiography

Detailed Description:

Hypotheses Primary Hypothesis: Compared to ICA, a diagnostic strategy algorithm using CTA for patients with HF of unknown etiology or where the definition of coronary anatomy is required for diagnosis and management, will result in a reduction in downstream resource utilization and per patient cost.

Secondary Hypotheses: I) Compared to standard care, a strategy that uses CTA will achieve: a) similar composite clinical events (CCE), quality of life (QoL), major adverse cardiac events (MACE); b) a lower rate of procedure related complications (death, MI, stroke, vascular complications, severe allergic reactions; contrast nephropathy); c) a lower rate of normal ICA. II) Using patient-based analysis and vessel-based analysis, CTA has very good agreement with ICA among patients with HF in the CTA arm who proceed to ICA.

Objectives The primary objective is to understand the role of CTA in patients with HF of unknown etiology. We propose a prospective randomized study of 250 patients to examine the potential impact of CTA compared to ICAon resource utilization and health care costs in patients with HF with unknown CAD status.

Secondary objectives are to: compare CCE, QoL and MACE in the CTA and ICA arms. Radiation exposure and safety in both groups will also be assessed.

Trial design The proposed trial is a multicentre randomized controlled trial of 250 patients. In addition, a retrospective review of the current CTA and ICA databases at the University of Ottawa Heart Institute will be conducted to identify an additional cohort of patients (200-400) where the imaging modality decision has already been made. These patients are not eligible for randomization, but will be entered into a registry.

Trial interventions - Randomization All HF patients requiring investigation to determine the etiology of HF (ischemic versus non-ischemic) will be screened for the study. Patients will be randomized to the investigation arm CTA or ICA. Patients will be stratified according to recruitment site and pre-test probability for obstructive CAD. A stratified block (varying sizes) randomization scheme will be used. Within each strata, patients will be randomized with varying block sizes into the two study groups. A central randomization scheme (envelope), which will ensure concealment, will be used and the local research co-ordinator will perform patient assignments. The randomization scheme will be generated by a statistician using a SAS macro.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Eligible HF patients with an admission to hospital or emergency room for heart failure

OR

a documented history of left ventricular dysfunction (LVEF <50%)

OR

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.

Exclusion criteria:

  1. Age < 18 years or lack of consent,
  2. Renal Insufficiency (GFR < 45 ml/min);
  3. Allergy to intravenous contrast agents;
  4. Contraindication to radiation exposure (e.g. pregnancy);
  5. Uncontrolled HR at time of scan (as per local clinical routine)
  6. History of revascularization (CABG or PCI);
  7. Atrial fibrillation, frequent atrial or ventricular ectopy (> 1 / minute);
  8. Unable to perform 20 second breath-hold;
  9. CTA or ICA within the preceding 12 months
  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: NCT01283659

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
University of Laval
Quebec City, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Finland
Helsinki University Central Hospital,
Helsinki, Finland
University of Kuopio
Kuopio, Finland
University of Turku
Turku, Finland
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 SB Beanlands, MD, FRCP C University of OttawaHeart Institute
Principal Investigator: Benjamin Chow, MD, FRCP C Ottawa Heart Institute Research Corporation
  More Information

Publications:
Responsible Party: Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01283659     History of Changes
Obsolete Identifiers: NCT01622985
Other Study ID Numbers: Project I-C
CIF-99470 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Study First Received: January 20, 2011
Last Updated: January 9, 2017

Keywords provided by Rob Beanlands, Ottawa Heart Institute Research Corporation:
computed tomographic angiography
coronary angiogram
cost effectiveness
QoL
Heart failure
diagnostic accuracy
prospective comparative effectiveness randomized clinical trial

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 22, 2017