Aortic AneurysmNCT06789809
Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue
A study testing Exercise MRI in people with Aortic Aneurysm, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Exercise MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2023to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy controls for baseline comparison
- Must be 18 years or older
- No history of cardiovascular disease, neither hypertension, diabetes nor hypercholesterolemia
- Aneurysm patients who have not yet been operated on but are currently being monitored
- Must be 18 years or older
- No history of operation for aortic aneurysm
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- Pre-operative aneurysm patients: imaged pre-operatively and 12 months
- Patients admitted at the CCF cardiothoracic services for elective surgery due to aortic aneurysms
- Must be 18 years or older
Who cannot join
- 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).
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- 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:
- Healthy controls for baseline comparison
- Excluded if using cardioprotective medication
- Have a bicuspid aortic valve diagnosed using MRI
- Pre-operative aneurysm patients: imaged pre-operatively and at 12 months a. Patients with traumatic aortic rupture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Jonathan Putnam
Deborah Kwon, MD
About this study
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.
- Conditions
- Aortic Aneurysm
- Being tested
- Exercise MRI
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise MRIDiagnostic test
Exercise stress MRI with ergometer
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Exercise MRI Receives: Diagnostic Test: Exercise MRI |
| Aneurysm Being Monitored | Experimental | Exercise MRI Receives: Diagnostic Test: Exercise MRI |
| Pre-operative Aneurysm Patients | Experimental | Exercise MRI Receives: Diagnostic Test: Exercise MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Compliance
Absolute change in arterial volume for a change in pressure
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 Nov 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Kwon, MD, The Cleveland Clinic
- Investigators
- Deborah Kwon, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789809
- Sponsor's protocol ID
- 20-310
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue
- ClinicalTrials.gov ID
- NCT06789809
- Acronym / sponsor ID
- 20-310
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Diagnostic Test: Exercise MRIExercise MRI |
| Aneurysm Being Monitored | Experimental | Diagnostic Test: Exercise MRIExercise MRI |
| Pre-operative Aneurysm Patients | Experimental | Diagnostic Test: Exercise MRIExercise MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy controls for baseline comparison
- Aneurysm patients who have not yet been operated on but are currently being monitored
- Pre-operative aneurysm patients: imaged pre-operatively and 12 months
Key exclusion criteria (22 listed)
- Contra-indication for MRI
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise MRIExercise stress MRI with ergometer | Diagnostic test | Aneurysm Being Monitored, Healthy Controls, Pre-operative Aneurysm Patients |
Primary outcome
Arterial Compliance
Time frame: up to 12 months
Absolute change in arterial volume for a change in pressure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Kwon, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise MRI in people with Aortic Aneurysm, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Putnam (740-701-8226, putnamj2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Compliance (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.