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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise MRI

    Diagnostic test

    Exercise stress MRI with ergometer

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Healthy ControlsExperimental treatment 1 intervention
Group B: Aneurysm Being MonitoredExperimental treatment 1 intervention
Group C: Pre-operative Aneurysm PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Arterial Compliance

Absolute change in arterial volume for a change in pressure

Time frame
up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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