Coronary Artery Disease Clinical Trial
Official title:
Evaluation of the Efficacy of Computed Tomographic Coronary Angiography in Assessing Coronary Artery Morphology and Physiology
NCT number | NCT03556644 |
Other study ID # | 17/0328 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | August 1, 2019 |
Verified date | September 2019 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Computed tomographic coronary angiography (CTCA) has been recently introduced to non-invasively evaluate coronary artery pathology. Histology and intravascular ultrasound imaging studies have demonstrated that CTCA enables identification of plaque characteristics associated with increased vulnerability (i.e., plaque burden and composition) and allows assessment of vessel physiology (i.e., local haemodynamic forces), and reports have shown that CTCA can predict atherosclerotic evolution and detect lesions that will progress and cause cardiovascular events. Despite the wealth of data provided, CTCA has still a limited role in the study of atherosclerosis. Prior to unlocking the full potential of CTCA and enable its broad use, further work is needed to develop user-friendly processing tools that will allow fast and accurate analysis of CTCA, and examine in detail the accuracy of modern CTCA imaging in assessing plaque pathology. In this application, the investigators aim 1) to develop a CTCA analysis system that will enable fast segmentation, reliable coronary reconstruction and blood flow simulation in a user-friendly environment and 2) validate the efficacy of state-of-the-art CTCA for assessment of coronary plaque morphology and physiology against intravascular plaque imaging using hybrid near infrared spectroscopy-intravascular ultrasound.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Patients with typical angina symptoms who had elective coronary angiography showing at least one lesion that requires further evaluation with intravascular coronary imaging or fractional flow reserve or it is considered suitable for percutaneous coronary intervention (PCI) under IVUS guidance will be included in the study Exclusion Criteria: 1. age >75 years 2. ACS within <3 months 3. eGFR <60ml/min/1.73m² 4. previous coronary artery bypass surgery 5. decompensated heart failure, or left ventricular ejection fraction =30% 6. intravenous contrast allergy or inability to receive treatment with aspirin, heparin, or thienopyridines 7. anticipated life expectancy <1 year 8. history of heart transplantation 9. patient that requires surgical revascularization 10. extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the coronary arteries with NIRS-IVUS imaging |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts Health NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability of CTCA in detecting fibroatheromas | Evaluation of the efficacy of CTCA in detecting fibroatheromas using NIRS-IVUS estimations as gold standard | Baseline CTCA | |
Secondary | Efficacy of CTCA in detecting lipid rich segments | Assessment of the accuracy of CTCA in detecting lipid rich plaques using NIRS-IVUS estimations as gold standard | Baseline CTCA | |
Secondary | Efficacy of CTCA in detecting segments exposed to a low ESS environment | Comparison of the estimations of the ESS computed in CTCA-based and NIRS-IVUS based reconstructions and evaluation of the accuracy of the CTCA based modeling in detecting low <1Pa ESS using the estimations of NIRS-IVUS based modeling as gold standard | Baseline CTCA |
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