Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis

NCT04344353 | Completed DMC

• 1 other identifier: 19-1139
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates and compares aortic calcium by computed tomography and histopathology in patients with aortic stenosis.

Conditions

Aortic Calcification Valve; Aortic Valve Stenosis

Keywords

Aortic valve stenosis; Computed Tomography; Histopathology analysis

Outcome Measures

Primary Outcomes (1)

• The quantifiable assessment and comparison of aortic valve calcium.

  The study of the valve, which is requested before surgery, will be analyzed in a tomography scan. The study will be performed with a multidetector with a double energy source of 256 cuts definition Flash Medical Systems Forcheim Germany (128 x 2). The images were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for Medicine). The results were expressed in Agatston units. The study was carried out without a contrast medium and with a radiation equivalent to 1.0 mSv. Employing the sample of the valve tissue obtained from the surgery, a 5-micron segment of the aortic valve, was washed in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in phosphate buffer with 10% formalin (pH 7.4) for 24 hours. The histopathological sample will be assessed by the head of the pathology department, which will result in the percentage of calcium observed.

  2 days

Secondary Outcomes (1)

• The quantifiable assessmen and comparisont of valve calcium with photomicrographs.

  7 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population will be the patients of the Instituto Nacional de Cardiología "Ignacio Chávez." The eligible population shall consist of patients from that Institute who have been diagnosed with severe aortic stenosis and who are in the hospitalization sectors and where aortic valve replacement with a mechanical or biological prosthesis is planned. Sampling: With a non-probabilistic sequential (consecutive) technique.

You may qualify if:

• Patients who are candidates for aortic valve replacement.
• Age greater than or equal to 18 years of age.
• Both genders.
• With any associated comorbidity
• Any etiology
• Hospitalized and with an echocardiographic study showing the variables to be studied
• Informed Consent.

You may not qualify if:

• Patients who have previously undergone other aortic valve surgery
• Patients who have received contrast medium ≤24 hours.
• Patients on hemodialysis.
• Patients with infection.
• Patients with cancer.
• Patients with autoimmune diseases.
• Pregnant women.
• Patients who refuse to be included.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional Ignacio Chavez

Mexico City, 14080, Mexico

Location

Related Publications (16)

• Otto CM, Kuusisto J, Reichenbach DD, Gown AM, O'Brien KD. Characterization of the early lesion of 'degenerative' valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 1994 Aug;90(2):844-53. doi: 10.1161/01.cir.90.2.844.

  PMID: 7519131 BACKGROUND

• Soto ME, Salas JL, Vargas-Barron J, Marquez R, Rodriguez-Hernandez A, Bojalil-Parra R, Perez-Torres I, Guarner-Lans V. Pre- and post-surgical evaluation of the inflammatory response in patients with aortic stenosis treated with different types of prosthesis. BMC Cardiovasc Disord. 2017 Apr 14;17(1):100. doi: 10.1186/s12872-017-0526-1.

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• Pawade TA, Newby DE, Dweck MR. Calcification in Aortic Stenosis: The Skeleton Key. J Am Coll Cardiol. 2015 Aug 4;66(5):561-77. doi: 10.1016/j.jacc.2015.05.066.

  PMID: 26227196 BACKGROUND

• Menon V, Lincoln J. The Genetic Regulation of Aortic Valve Development and Calcific Disease. Front Cardiovasc Med. 2018 Nov 6;5:162. doi: 10.3389/fcvm.2018.00162. eCollection 2018.

  PMID: 30460247 BACKGROUND

• Kostyunin AE, Yuzhalin AE, Ovcharenko EA, Kutikhin AG. Development of calcific aortic valve disease: Do we know enough for new clinical trials? J Mol Cell Cardiol. 2019 Jul;132:189-209. doi: 10.1016/j.yjmcc.2019.05.016. Epub 2019 May 25.

  PMID: 31136747 BACKGROUND

• Small A, Kiss D, Giri J, Anwaruddin S, Siddiqi H, Guerraty M, Chirinos JA, Ferrari G, Rader DJ. Biomarkers of Calcific Aortic Valve Disease. Arterioscler Thromb Vasc Biol. 2017 Apr;37(4):623-632. doi: 10.1161/ATVBAHA.116.308615. Epub 2017 Feb 2.

  PMID: 28153876 BACKGROUND

• Chin CW, Pawade TA, Newby DE, Dweck MR. Risk Stratification in Patients With Aortic Stenosis Using Novel Imaging Approaches. Circ Cardiovasc Imaging. 2015 Aug;8(8):e003421. doi: 10.1161/CIRCIMAGING.115.003421. No abstract available.

  PMID: 26198161 BACKGROUND

• Aggarwal SR, Clavel MA, Messika-Zeitoun D, Cueff C, Malouf J, Araoz PA, Mankad R, Michelena H, Vahanian A, Enriquez-Sarano M. Sex differences in aortic valve calcification measured by multidetector computed tomography in aortic stenosis. Circ Cardiovasc Imaging. 2013 Jan 1;6(1):40-7. doi: 10.1161/CIRCIMAGING.112.980052. Epub 2012 Dec 10.

  PMID: 23233744 BACKGROUND

• Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.

  PMID: 24076528 BACKGROUND

• Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.

  PMID: 29555836 BACKGROUND

• Glasziou P, Irwig L, Deeks JJ. When should a new test become the current reference standard? Ann Intern Med. 2008 Dec 2;149(11):816-22. doi: 10.7326/0003-4819-149-11-200812020-00009.

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• Messika-Zeitoun D, Aubry MC, Detaint D, Bielak LF, Peyser PA, Sheedy PF, Turner ST, Breen JF, Scott C, Tajik AJ, Enriquez-Sarano M. Evaluation and clinical implications of aortic valve calcification measured by electron-beam computed tomography. Circulation. 2004 Jul 20;110(3):356-62. doi: 10.1161/01.CIR.0000135469.82545.D0. Epub 2004 Jul 12.

  PMID: 15249504 BACKGROUND

• Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.

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• Ajlan M, Ahmed A, Alskaini AM, Abukhaled NF, Alsaileek A, Ajlan A, Sulaiman IF, Al-Mallah MH. The reproducibility of coronary artery calcium scoring on different software platforms. Int J Cardiol. 2015;187:155-6. doi: 10.1016/j.ijcard.2015.03.133. Epub 2015 Mar 19. No abstract available.

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  PMID: 22771886 BACKGROUND

• Baumgartner H Chair, Hung J Co-Chair, Bermejo J, Chambers JB, Edvardsen T, Goldstein S, Lancellotti P, LeFevre M, Miller F Jr, Otto CM. Recommendations on the echocardiographic assessment of aortic valve stenosis: a focused update from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):254-275. doi: 10.1093/ehjci/jew335.

  PMID: 28363204 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A 5-micron segment of the aortic valve, obtained by cardiothoracic surgery.

MeSH Terms

Conditions

Aortic Valve, Calcification of; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy of the Immunology Department.

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 14, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

Locations

ME (1)