Actively Recruiting

Age: 18Years +
All Genders
ID07453251

Strength Tracking From Wall Thickness Over Aortic Biomechanics

Led by IRCCS Policlinico S. Donato · Updated on 2026-03-11

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

IRCCS Policlinico S. Donato

Lead Sponsor

U

University of Pavia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the strength and mechanical properties of the ascending aorta affected by aneurysms. This study aims to analyze the resected aortic tissue from patients undergoing surgery to assess its strength to rupture, stiffness, and other characteristics. The goal is to better understand how these properties relate to aortic diameter, valve shape, and wall thickness to improve surgical decision-making. Participants in this observational study are patients having cardiac surgery for aortic root or ascending aortic aneurysms. The resected aortic tissue will be examined in the laboratory to measure its strength to rupture and evaluate various aortic features. These measurements will be standardized and correlated with clinical data to provide insights on the fragility of the aneurysmatic aorta. During the study, tissue samples collected during surgery will undergo laboratory testing to assess mechanical strength. Researchers will also review aortic characteristics from surgery through lab analysis. The main outcome measured is the strength of the aortic tissue to rupture during testing. Participation involves undergoing surgery as part of routine care, with additional laboratory evaluations of the removed tissue. The study is expected to continue until December 2026.

CONDITIONS

Brief Title

Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing cardiac surgery for either aortic root and/or ascending aortic aneurysms
  • Patients who have received, understood, and signed the written informed consent for this study
Not Eligible

You will not qualify if you...

  • Patients who have previously undergone cardiac surgery
  • Patients with acute aortic conditions such as acute aortic dissection or intramural hematoma

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo cardiac surgery for aortic root and/or ascending aortic aneurysms during which aortic tissue is collected for analysis.

1 visit (in-person)

Laboratory Testing

Duration - From surgery to laboratory testing

Collected aortic tissue is tested in the laboratory to assess strength to rupture and mechanical characteristics.

No participant visits; laboratory analysis only

Trial Site Locations

Total: 1 location

1

IRCCS Policlinico San Donato

San Donato Milanese, MI, Italy, 20097

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Determination of the elastic modulus of ascending thoracic aortic aneurysm at different ranges of pressure using uniaxial tensile testing.

Khalil Khanafer, Ambroise Duprey, Mohammad Zainal...

https://pubmed.ncbi.nlm.nih.gov/21616506

Histological regional analysis of the aortic root and thoracic ascending aorta: a complete analysis of aneurysms from root to arch.

Timothy Luke Surman, John Matthew Abrahams, Jim Manavis...

https://pubmed.ncbi.nlm.nih.gov/34496896

Engineering analysis of aortic wall stress and root dilatation in the V-shape surgery for treatment of ascending aortic aneurysms.

Hai Dong, Minliang Liu, Tongran Qin...

https://pubmed.ncbi.nlm.nih.gov/35134955

The combined impact of mechanical factors on the wall stress of the human ascending aorta - a finite elements study.

Tomasz Plonek, Malgorzata Zak, Karolina Burzynska...

https://pubmed.ncbi.nlm.nih.gov/29262774