search
Back to results

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement. (CORONATE)

Primary Purpose

Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CT scan with contrast medium
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Valve Diseases focused on measuring Aortic valve replacement, Aortic valve bioprosthesis, Coronary ostia obstruction, Valve-in-valve, Transcatheter aortic valve implantation, Aortic valve stenosis, Tricuspid aortic valve, Aortic valve regurgitation, CT coronary angiogram, Transcatheter aortic valve replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years; Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis; Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization; CT imaging of the thorax with iodinated contrast agent carried out before surgery; Signed informed consent, inclusive of release of medical information. Exclusion Criteria: Aortic valve replacement in bicuspid valve or endocarditis; Aortic valve replacement associated with surgery of ascending aorta/aortic root; Aortic valve replacement associated with other cardiac valve surgery; Previous cardiac surgery of any kind; Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator; Participation in another clinical trial that could interfere with the endpoints of this study; Pregnant or breastfeeding at time of screening; Allergy or hypersensitivity to iodinated contrast agent; End-stage renal disease on dialysis. Childbearing-aged women or men with childbearing-aged partner.

Sites / Locations

  • Policlinico Agostino Gemelli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical Aortic Valve Replacement

Arm Description

Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.

Outcomes

Primary Outcome Measures

Coronary ostia height differences.
Differences in coronary ostia height before and after surgical aortic valve replacement.

Secondary Outcome Measures

Coronary ostia height differences between different bioprostheses.
Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.
Coronary ostia height differences between different surgical techniques.
Differences in coronary ostia height before and after surgical aortic valve replacement according to different surgical technique used.

Full Information

First Posted
January 27, 2023
Last Updated
September 11, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05714293
Brief Title
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Acronym
CORONATE
Official Title
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.
Detailed Description
Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center. Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis or surgical technique used (infra-annular or supra-annular technique). All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic, Stenoses, Aortic, Aortic Regurgitation, Aortic Stenosis, Severe, Coronary; Obstruction, Valve Disease, Aortic
Keywords
Aortic valve replacement, Aortic valve bioprosthesis, Coronary ostia obstruction, Valve-in-valve, Transcatheter aortic valve implantation, Aortic valve stenosis, Tricuspid aortic valve, Aortic valve regurgitation, CT coronary angiogram, Transcatheter aortic valve replacement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Aortic Valve Replacement
Arm Type
Experimental
Arm Description
Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.
Intervention Type
Radiation
Intervention Name(s)
CT scan with contrast medium
Other Intervention Name(s)
CT scan
Intervention Description
Multislice CT scan (if possible retrospectively EKG-gated) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement.
Primary Outcome Measure Information:
Title
Coronary ostia height differences.
Description
Differences in coronary ostia height before and after surgical aortic valve replacement.
Time Frame
At least 90 days after surgery
Secondary Outcome Measure Information:
Title
Coronary ostia height differences between different bioprostheses.
Description
Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.
Time Frame
At least 90 days after surgery
Title
Coronary ostia height differences between different surgical techniques.
Description
Differences in coronary ostia height before and after surgical aortic valve replacement according to different surgical technique used.
Time Frame
At least 90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis; Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization; CT imaging of the thorax with iodinated contrast agent carried out before surgery; Signed informed consent, inclusive of release of medical information. Exclusion Criteria: Aortic valve replacement in bicuspid valve or endocarditis; Aortic valve replacement associated with surgery of ascending aorta/aortic root; Aortic valve replacement associated with other cardiac valve surgery; Previous cardiac surgery of any kind; Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator; Participation in another clinical trial that could interfere with the endpoints of this study; Pregnant or breastfeeding at time of screening; Allergy or hypersensitivity to iodinated contrast agent; End-stage renal disease on dialysis. Childbearing-aged women or men with childbearing-aged partner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Massetti, MD
Organizational Affiliation
Policlinico Agostino Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9060903
Citation
Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.
Results Reference
background
PubMed Identifier
34453165
Citation
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available. Erratum In: Eur Heart J. 2022 Feb 18;:
Results Reference
background
PubMed Identifier
21924147
Citation
Dunning J, Gao H, Chambers J, Moat N, Murphy G, Pagano D, Ray S, Roxburgh J, Bridgewater B. Aortic valve surgery: marked increases in volume and significant decreases in mechanical valve use--an analysis of 41,227 patients over 5 years from the Society for Cardiothoracic Surgery in Great Britain and Ireland National database. J Thorac Cardiovasc Surg. 2011 Oct;142(4):776-782.e3. doi: 10.1016/j.jtcvs.2011.04.048.
Results Reference
background
PubMed Identifier
28874031
Citation
Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.
Results Reference
background
PubMed Identifier
32470529
Citation
Giordana F, Bruno F, Conrotto F, Saglietto A, D'Ascenzo F, Grosso Marra W, Dvir D, Webb J, D'Onofrio A, Camboni D, Grubitzsch H, Duncan A, Kaneko T, Toggweiler S, Latib A, Nerla R, Salizzoni S, La Torre M, Trompeo A, D'Amico M, Rinaldi M, De Ferrari G. Incidence, predictors and outcomes of valve-in-valve TAVI: A systematic review and meta-analysis. Int J Cardiol. 2020 Oct 1;316:64-69. doi: 10.1016/j.ijcard.2020.05.058. Epub 2020 May 26.
Results Reference
background
PubMed Identifier
31508426
Citation
Bernardi FLM, Dvir D, Rodes-Cabau J, Ribeiro HB. Valve-in-Valve Challenges: How to Avoid Coronary Obstruction. Front Cardiovasc Med. 2019 Aug 23;6:120. doi: 10.3389/fcvm.2019.00120. eCollection 2019.
Results Reference
background
PubMed Identifier
33236042
Citation
Coti I, Maierhofer U, Rath C, Werner P, Loewe C, Kocher A, Laufer G, Andreas M. Effect of conventional and rapid-deployment aortic valve replacement on the distance from the aortic annulus to coronary arteries. Interact Cardiovasc Thorac Surg. 2021 Jan 22;32(2):196-203. doi: 10.1093/icvts/ivaa247.
Results Reference
background
PubMed Identifier
31431105
Citation
Bruno P, Cammertoni F, Rosenhek R, Mazza A, Pavone N, Iafrancesco M, Nesta M, Chiariello GA, Spalletta C, Graziano G, Sanesi V, D'Errico D, Massetti M. Improved Patient Recovery With Minimally Invasive Aortic Valve Surgery: A Propensity-Matched Study. Innovations (Phila). 2019 Oct;14(5):419-427. doi: 10.1177/1556984519868715. Epub 2019 Aug 21.
Results Reference
background
PubMed Identifier
23701088
Citation
Freeman LA, Young PM, Foley TA, Williamson EE, Bruce CJ, Greason KL. CT and MRI assessment of the aortic root and ascending aorta. AJR Am J Roentgenol. 2013 Jun;200(6):W581-92. doi: 10.2214/AJR.12.9531.
Results Reference
background
PubMed Identifier
25310413
Citation
Salgado RA, Leipsic JA, Shivalkar B, Ardies L, Van Herck PL, Op de Beeck BJ, Vrints C, Rodrigus I, Parizel PM, Bosmans J. Preprocedural CT evaluation of transcatheter aortic valve replacement: what the radiologist needs to know. Radiographics. 2014 Oct;34(6):1491-514. doi: 10.1148/rg.346125076. Erratum In: Radiographics. 2015 Jan-Feb;35(1):299.
Results Reference
background
PubMed Identifier
28540072
Citation
Salemi A, Worku BM. Standard imaging techniques in transcatheter aortic valve replacement. J Thorac Dis. 2017 Apr;9(Suppl 4):S289-S298. doi: 10.21037/jtd.2017.03.114.
Results Reference
background

Learn more about this trial

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

We'll reach out to this number within 24 hrs