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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Diagnostic test: Exercise MRI

Detailed Description

Engaging in regular exercise in controls lowers blood pressure over time, and this is associated with a lower risk of future aortic complications. However, it is not known what level of exercise is safe for aneurysm patients.

Cardiac MRI (CMR) is the most comprehensive imaging modality for phenotypic evaluation of patients with cardiac disease. It has been limited in its use because exercise stress MRI is not widely available due to the need for MRI safe exercise equipment. However, the Cleveland Clinic has purchased a Lode MRI compatible exercise ergometer that is FDA approved and compatible with our 3T cardiac MRI scanner.

By conducting a study using this imaging modality we will be able to observe aortic blood flow, specifically compliance, distensibility, maximum rates of systolic distension and diastolic recoil, at different locations along the ascending and descending aorta, as well as aortic pulse wave velocity. A more comprehensive analysis of these variables will be critical to understanding how the aorta responds during times of stress in aneurysm patients.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Putnam; Phone Number: 740-701-8226; Email: putnamj2@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Sub-Investigator: Deborah Kwon, MD
      • Contact: Jonathan Putnam
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy controls for baseline comparison

   1. Must be 18 years or older
   2. No history of cardiovascular disease, neither hypertension, diabetes nor hypercholesterolemia

2. Aneurysm patients who have not yet been operated on but are currently being monitored

   1. Must be 18 years or older
   2. No history of operation for aortic aneurysm

3. Pre-operative aneurysm patients: imaged pre-operatively and 12 months

   1. Patients admitted at the CCF cardiothoracic services for elective surgery due to aortic aneurysms
   2. Must be 18 years or older

Exclusion Criteria:

For all patients:

• Contra-indication for MRI

  • Heart pacemaker/defibrillator.
  • Electronic/implanted stimulators or devices, including deep brain stimulator, vagus nerve stimulator, bladder stimulator, spine stimulator, neurostimulators; implanted electrodes or wires.
  • Cochlear implant or other ear implants.
  • Implanted drug pumps (insulin, narcotic/pain medications, drugs to treat spasticity).
  • Programmable shunt.
  • Aneurysm clips and coils.
  • Stents (not located in heart).
  • Filters (for example, blood clot filters).
  • Metal fragment in your body or eye (eg, BBs, bullets, shrapnel, metal pieces or shavings).
• Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
• Presence of A-V fistula or intracardiac shunts
• Moderate or severe dysfunction in multiple valves
• Patients with significant claustrophobia
• Patients unable to pedal a supine bicycle
• Those who require supplemental oxygen

Specific Exclusion Criteria:

1. Healthy controls for baseline comparison

   1. Excluded if using cardioprotective medication
   2. Have a bicuspid aortic valve diagnosed using MRI
2. Pre-operative aneurysm patients: imaged pre-operatively and at 12 months a. Patients with traumatic aortic rupture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Controls; Exercise MRI	Diagnostic test: Exercise MRI; Exercise stress MRI with ergometer
Experimental: Aneurysm Being Monitored; Exercise MRI	Diagnostic test: Exercise MRI; Exercise stress MRI with ergometer
Experimental: Pre-operative Aneurysm Patients; Exercise MRI	Diagnostic test: Exercise MRI; Exercise stress MRI with ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Compliance	Absolute change in arterial volume for a change in pressure	up to 12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Deborah Kwon, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 20-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No