ClinicalTrials.gg
RecruitingNCT06789809Updated Jan 2, 2026

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

An interventional study of Exercise MRI in Aortic Aneurysm, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2023, registered Jan 2025).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Aortic Aneurysm

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03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 35 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

For all patients:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Healthy Controls

    Exercise MRI

    Diagnostic Test: Exercise MRI

  • Experimental
    Aneurysm Being Monitored

    Exercise MRI

    Diagnostic Test: Exercise MRI

  • Experimental
    Pre-operative Aneurysm Patients

    Exercise MRI

    Diagnostic Test: Exercise MRI

Interventions

  • Diagnostic testExercise MRI

    Exercise stress MRI with ergometer

06

What researchers measure

Primary outcomes

  1. Arterial Compliance

    Absolute change in arterial volume for a change in pressure

    Time frame: up to 12 months

07

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    Recruiting
    • Jonathan Putnam · Contact
    • 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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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06789809
Responsible party
Deborah Kwon, MD (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Jan 23, 2025
Start date
Nov 23, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jan 2, 2026

Study contacts

Jonathan Putnam
Contact
putnamj2@ccf.org
740-701-8226
Deborah Kwon, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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