Understanding exercise effects on aortic aneurysm patients

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

This study is testing how exercise affects people with aortic aneurysms to help find safe activity levels that could improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06789809 on ClinicalTrials.gov

What this trial studies

This project investigates how exercise impacts patients with aortic aneurysms by utilizing cardiac MRI to assess aortic function and elasticity during physical activity. The study aims to correlate exercise-induced changes in aortic properties with biomechanical characteristics of the aortic tissue, using advanced imaging techniques and mechanical testing. By analyzing these relationships, the research seeks to establish safe exercise levels for aneurysm patients, potentially improving their management and outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with aortic aneurysms who are being monitored and have not yet undergone surgery.

Not a fit: Patients with contraindications for MRI or those who have a history of cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine safe exercise levels for patients with aortic aneurysms, potentially reducing their risk of complications.

How similar studies have performed: While exercise physiology has been studied in other cardiac conditions, the specific application of exercise MRI in aortic aneurysm patients is novel and has not been extensively tested.

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Deborah Kwon, MD — The Cleveland Clinic
• Study coordinator: Jonathan Putnam

Conditions: Aortic Aneurysm