Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01283659
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2011-01-20
Brief Title:
IMAGE-HF Project I-C Computed Tomographic Coronary Angiography for Heart Failure Patients
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTA-HF
Brief 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 ie 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
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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIF-99470 | OTHER_GRANT | Canadian Institutes of Health Research | None |