NCT06789809 · The Cleveland Clinic
Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
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:
- 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
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 2, 2026 · Source of record for eligibility and locations