NCT06789809 Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue
| NCT ID | NCT06789809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2023-11-23 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Deborah Kwon, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06789809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789809 currently recruiting?
Yes, NCT06789809 is actively recruiting participants. Contact the research team at putnamj2@ccf.org for enrollment information.
Where is the NCT06789809 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06789809 clinical trial?
NCT06789809 is sponsored by The Cleveland Clinic. The principal investigator is Deborah Kwon, MD at The Cleveland Clinic. The trial plans to enroll 35 participants.