Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06789809
Status
Recruiting
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Conditions

  • Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exercise MRI — DIAGNOSTIC_TEST
    Exercise stress MRI with ergometer

Study Details

Aortic aneurysm patients benefit from exercise yet patients and physicians do not know a safe level. Cardiac MRI (CMR) is the most comprehensive imaging modality for phenotypic evaluation of patients with cardiac disease but it has not been used to study aneurysm patients. The purpose of this project is use exercise CMR to understand regional aortic function and quantify aortic elasticity in these populations while exercising. This project will correlate the exercise CMR data with the biomechanical properties of the patient's aortic tissue, including epiaortic ultrasound and TEE performed during aortic repair, and explanted aortic specimens subjected to ex vivo uniaxial tensile testing. Correlating this data with aortic response to exercise will allow us to understand how aortic size, in vivo circumferential strain values, ex vivo aortic efficiency and mechanical failure all relate to exercise physiology.

Key Dates

Start date
Nov 23, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Controls
    Exercise MRI
  • Experimental: Aneurysm Being Monitored
    Exercise MRI
  • Experimental: Pre-operative Aneurysm Patients
    Exercise MRI

Primary Outcome Measure

Arterial Compliance [ Time Frame: up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Jonathan Putnam
Deborah Kwon, MD (SUB_INVESTIGATOR)
Milind Desai, MD (SUB_INVESTIGATOR)
Eugene Blackstone, MD (SUB_INVESTIGATOR)
Erik Van Iterson, PhD (SUB_INVESTIGATOR)
Suneel Apte, PhD (SUB_INVESTIGATOR)
Jeanna Sigmund, CNP (SUB_INVESTIGATOR)

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