Heart FailureCTA-HFNCT01283659
IMAGE-HF Project I-C: Computed Tomographic Coronary Angiography for Heart Failure Patients
A study testing Standard Imaging and Advanced Imaging in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Standard Imaging and Advanced Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Feb 2011to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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);
Show all 9Show fewer
- Atrial fibrillation, frequent atrial or ventricular ectopy (> 1 / minute);
- Unable to perform 20 second breath-hold;
- CTA or ICA within the preceding 12 months
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Canada12 sites
University of Calgary
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Dalhousie University
Halifax, Nova Scotia
Hamilton Health Sciences Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Montreal Heart Institute
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
University of Laval
Québec, Quebec
Université de Sherbrooke
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
University of Manitoba
Winnipeg, Manitoba
Finland3 sites
Helsinki University Central Hospital,
Helsinki
University of Kuopio
Kuopio
University of Turku
Turku
About this study
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)
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Standard Imaging, Advanced Imaging
- Keywords
- computed tomographic angiography, coronary angiogram, cost effectiveness, QoL, Heart failure, diagnostic accuracy, prospective comparative effectiveness randomized clinical trial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ImagingOther
Also called Coronary Angiography
Advanced ImagingOther
Also called Coronary Computed Tomographic Angiography
| Study group | Role | What they receive |
|---|---|---|
| Standard imaging (coronary angiography) | Active comparator | Subjects will undergo a coronary angiogram as planned by their attending doctor Receives: 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. Receives: Other: Advanced Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 12 months
Secondary outcomes (2)
Clinical Endpoints
CCE, LV Function, QoL, and Safety: will measured.
Measured: 3 and 12 months
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation
- Responsible party
- Principal investigator, Rob Beanlands, Ottawa Heart Institute Research Corporation
- Investigators
- Rob SB Beanlands, MD, FRCP C, Study director, University of OttawaHeart InstituteBenjamin Chow, MD, FRCP C, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283659
- Sponsor's protocol ID
- Project I-C
- Other IDs
- CIF-99470
- Acronym
- CTA-HF
- Status last verified
- Nov 2019
- First submitted
- 20 Jan 2011
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21297464Chow 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.
PubMed 24369097Chow 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.
PubMed 32588042
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01283659
- Acronym / sponsor ID
- CTA-HF / Project I-C
- Conditions
- Heart Failure
- Keywords
- computed tomographic angiography, coronary angiogram, cost effectiveness, QoL, Heart failure, diagnostic accuracy, prospective comparative effectiveness randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation
- Study start
- Feb 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard imaging (coronary angiography) | Active comparator | Other: Standard ImagingSubjects will undergo a coronary angiogram as planned by their attending doctor |
| Advanced imaging (CTA) | Active comparator | Other: Advanced ImagingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ImagingAlso: Coronary Angiography | Other | Standard imaging (coronary angiography) |
| Advanced ImagingAlso: Coronary Computed Tomographic Angiography | Other | Advanced imaging (CTA) |
Primary outcome
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.
2 secondary outcomes
Clinical Endpoints
Time frame: 3 and 12 months
CTA Accuracy
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 21297464Paterson 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.
- Background: PubMed 24369097Chow 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.
- Derived from this study: PubMed 32588042Chow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob SB Beanlands, MD, FRCP C study director
University of OttawaHeart Institute
Benjamin Chow, MD, FRCP C principal investigator
Ottawa Heart Institute Research Corporation
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Imaging and Advanced Imaging in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource Utilization (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.