Evaluation of CTCA in Assessing Plaque Pathology and Physiology

NCT03556644 | Completed

• 1 other identifier: 17/0328
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Near Infrared Spectroscopy; Computed Tomography Coronary Angiography; Atherosclerosis; Endothelial Shear Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy of CTCA in detecting lipid rich segments

  Baseline CTCA

• Efficacy of CTCA in detecting segments exposed to a low ESS environment

  Baseline CTCA

Study Arms (1)

Single arm study

OTHER

70 patients with coronary artery disease will have CTCA imaging and 3 vessel intravascular imaging with NIRS-IVUS during percutaneous coronary intervention and the obtained imaging data will be used to assess the efficacy of CTCA in detecting plaque morphology and shear stress distribution.

Radiation: CTCA imaging

Interventions

CTCA imaging RADIATION

All the studied patients will have CTCA before percutaneous coronary intervention and 3 vessel NIRS-IVUS imaging during percutaneous coronary intervention

Also known as: NIRS-IVUS imaging

Single arm study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age \>75 years
• ACS within \<3 months
• eGFR \<60ml/min/1.73m²
• previous coronary artery bypass surgery
• decompensated heart failure, or left ventricular ejection fraction ≤30%
• intravenous contrast allergy or inability to receive treatment with aspirin, heparin, or thienopyridines
• anticipated life expectancy \<1 year
• history of heart transplantation
• patient that requires surgical revascularization
• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Related Publications (2)

• Ramasamy A, Sokooti H, Zhang X, Tzorovili E, Bajaj R, Kitslaar P, Broersen A, Amersey R, Jain A, Ozkor M, Reiber JHC, Dijkstra J, Serruys PW, Moon JC, Mathur A, Baumbach A, Torii R, Pugliese F, Bourantas CV. Novel near-infrared spectroscopy-intravascular ultrasound-based deep-learning methodology for accurate coronary computed tomography plaque quantification and characterization. Eur Heart J Open. 2023 Oct 30;3(5):oead090. doi: 10.1093/ehjopen/oead090. eCollection 2023 Sep.

  PMID: 37908441 DERIVED

• Ramasamy A, Hamid A Khan A, Cooper J, Simon J, Maurovich-Horvat P, Bajaj R, Kitslaar P, Amersey R, Jain A, Deaner A, Reiber JH, Moon JC, Dijkstra J, Serruys PW, Mathur A, Baumbach A, Torii R, Pugliese F, Bourantas CV. Implications of computed tomography reconstruction algorithms on coronary atheroma quantification: Comparison with intravascular ultrasound. J Cardiovasc Comput Tomogr. 2023 Jan-Feb;17(1):43-51. doi: 10.1016/j.jcct.2022.09.004. Epub 2022 Sep 21.

  PMID: 36270952 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: March 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

GB (1)