Recruiting

Exercise CMR

Sponsor:

The Cleveland Clinic

Code:

NCT06789809

Conditions

Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exercise MRI

Study Details

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.

Conditions

Aortic Aneurysm

Study ID

NCT06789809

Start date

Nov 23, 2023

Status verified date

Dec, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Controls

Exercise MRI

experimental: Aneurysm Being Monitored

Exercise MRI

experimental: Pre-operative Aneurysm Patients

Exercise MRI

Interventions

Exercise MRI

Exercise stress MRI with ergometer

Primary outcome measure

  • Arterial Compliance [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Jonathan Putnam

740-701-8226putnamj2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-02.