Heart Failure Clinical Trial
— CTA-HFOfficial 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)
Verified date | November 2019 |
Source | Ottawa Heart Institute Research Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 253 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Alberta | Edmonton | Alberta |
Canada | Dalhousie University | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences Centre | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | University of Laval | Quebec City | Quebec |
Canada | Université de Sherbrooke | Sherbrooke | Quebec |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University of Manitoba | Winnipeg | Manitoba |
Finland | Helsinki University Central Hospital, | Helsinki | |
Finland | University of Kuopio | Kuopio | |
Finland | University of Turku | Turku |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation | Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation (TEKES) |
Canada, Finland,
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Clinical Endpoints | CCE, LV Function, QoL, and Safety: will measured. | 3 and 12 months | |
Secondary | CTA Accuracy | 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). | Baseline |
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