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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Ottawa Heart Institute Research Corporation
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: June 15, 2015
Last verified: June 2015
  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: 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 Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Resource Utilization [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    CCE, LV Function, QoL, and Safety: will measured.

  • CTA Accuracy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 250
Study Start Date: February 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Linda M Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Todd Anderson, MD         
Principal Investigator: Matthias Friedrich, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Ian Paterson, MD         
Principal Investigator: Ian Paterson, MD         
Canada, Manitoba
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Malek Kass, MD         
Sub-Investigator: Malek Kass, MD         
Sub-Investigator: James Tan, MD         
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada
Contact: Miroslaw Rajda, MD       Miroslaw.Rajda@cdha.nshealth.ca   
Principal Investigator: Miroslaw Rajda, MD         
Sub-Investigator: James Clarke, MD         
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada
Contact: Karen Gulenchyn, MD         
Principal Investigator: Karen Gulenchyn, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Malcolm Arnold, MD         
Principal Investigator: Malcolm Arnold, MD         
Sub-Investigator: Gerald Wisenberg, MD         
Sub-Investigator: James White, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Linda M Garrard, RN, BScN    613-761-4192    lgarrard@ottawaheart.ca   
Sub-Investigator: Rob S. Beanlands, MD, FRCP C         
Sub-Investigator: Lisa Mielniczuk, MD, FRCP C         
Sub-Investigator: George A Wells, PhD         
Sub-Investigator: Robert A. deKemp, PhD         
Principal Investigator: Benjamin Chow, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Graham Wright, MD    (416)480-6869    gawright@sri.utoronto.ca   
Principal Investigator: Graham Wright, MD         
Principal Investigator: Kim Connelly, MD         
Sub-Investigator: Charles Cunningham Cunningham, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Kim Connelly, MD    14168645201    connellyk@smh.ca   
Principal Investigator: Kim Connelly, MD         
Sub-Investigator: Michael Freeman, MD         
Sub-Investigator: Howard Leong-Poi, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Eileen O'Meara, MD         
Principal Investigator: Eileen O'Meara, MD         
Sub-Investigator: Jean-Claude Tardif, MD         
University of Laval Recruiting
Quebec City, Quebec, Canada
Contact: Philippe Pibarot, MD         
Principal Investigator: Philippe Pibarot, MD         
Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: Eric Turcotte, MD         
Principal Investigator: Eric Turcotte, MD         
Sub-Investigator: Serge Lepage, MD         
Sub-Investigator: Paul Pharand, MD         
Finland
Helsinki University Central Hospital, Recruiting
Helsinki, Finland
Contact: Mika Laine, MD    358 405 245735    Mika.Laine@hus.fi   
Principal Investigator: Mika Laine, MD         
University of Kuopio Recruiting
Kuopio, Finland
Contact: Juha Hartikainen, MD    044-711 3945    Juha.Hartikainen@kuh.fi   
Principal Investigator: Juha Hartikainen, MD         
Sub-Investigator: Satu Karkkainen, M D         
University of Turku Recruiting
Turku, Finland
Contact: Juhani Knuuti, MD         
Principal Investigator: Juhani Knuuti, MD         
Sub-Investigator: Heikki Ukkonen, MD         
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
Other Study ID Numbers: Project I-C, CIF-99470
Study First Received: January 20, 2011
Last Updated: June 15, 2015
Health Authority: Canada: Health Canada

Keywords provided by 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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 01, 2015