Detection of Proximal Coronary Artery Disease in the Work-up for Transcatheter Aortic Valve Implantation Using CTA (From the DEPICT CTA Database)

NCT04491513 | Completed

• 1 other identifier: Amsterdam UMC
• Study Type: observational
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Computed tomography angiography (CTA) is already used in the work-up for transcatheter aortic valve implantation (TAVI) and could partially replace invasive coronary angiography (CAG) to rule out proximal coronary lesions. Objectives: To assess the diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level. Methods: The DEPICT CTA database consists of individual patient data of four studies that analysed the diagnostic accuracy of pre-TAVI CTA to detect coronary lesions. For this analysis, diagnostic accuracy was assessed in the left main and the three proximal coronary segments.

Conditions

Computed Tomography Angiography; Coronary Artery Disease; Coronary Angriography; Aortic Valve Disease

Keywords

Computed tomography angiography; coronary angriography; Aortic Valve Disease; Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level.

  1 year

Study Arms (1)

Overall cohort

Pateints that underwent both CTA and CAG in the work-up for TAVI

Diagnostic Test: Computed tomography angiography

Interventions

Computed tomography angiography DIAGNOSTIC_TEST

Computed tomography angiography for the detection of proximal coronary lesions in patients in the work-up for TAVI

Overall cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the work-up for TAVI

You may qualify if:

• Patients in the work-up for TAVI

You may not qualify if:

• inability to undergo CTA

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (4)

• Andreini D, Pontone G, Mushtaq S, Bartorelli AL, Ballerini G, Bertella E, Segurini C, Conte E, Annoni A, Baggiano A, Formenti A, Fusini L, Tamborini G, Alamanni F, Fiorentini C, Pepi M. Diagnostic accuracy of multidetector computed tomography coronary angiography in 325 consecutive patients referred for transcatheter aortic valve replacement. Am Heart J. 2014 Sep;168(3):332-9. doi: 10.1016/j.ahj.2014.04.022. Epub 2014 Jun 9.

  PMID: 25173545 BACKGROUND

• Opolski MP, Kim WK, Liebetrau C, Walther C, Blumenstein J, Gaede L, Kempfert J, Van Linden A, Walther T, Hamm CW, Mollmann H. Diagnostic accuracy of computed tomography angiography for the detection of coronary artery disease in patients referred for transcatheter aortic valve implantation. Clin Res Cardiol. 2015 Jun;104(6):471-80. doi: 10.1007/s00392-014-0806-z. Epub 2015 Jan 6.

  PMID: 25559245 BACKGROUND

• Hamdan A, Wellnhofer E, Konen E, Kelle S, Goitein O, Andrada B, Raanani E, Segev A, Barbash I, Klempfner R, Goldenberg I, Guetta V. Coronary CT angiography for the detection of coronary artery stenosis in patients referred for transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2015 Jan-Feb;9(1):31-41. doi: 10.1016/j.jcct.2014.11.008. Epub 2014 Dec 3.

  PMID: 25576406 BACKGROUND

• Rossi A, De Cecco CN, Kennon SRO, Zou L, Meinel FG, Toscano W, Segreto S, Achenbach S, Hausleiter J, Schoepf UJ, Pugliese F. CT angiography to evaluate coronary artery disease and revascularization requirement before trans-catheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2017 Sep-Oct;11(5):338-346. doi: 10.1016/j.jcct.2017.06.001. Epub 2017 Jun 22.

  PMID: 28662835 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: October 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: data will be made available upon publication

Locations

NL (1)