NCT06789809

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
35mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Nov 2023Mar 2029

Study Start

First participant enrolled

November 23, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5.1 years

First QC Date

January 17, 2025

Last Update Submit

December 28, 2025

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Arterial Compliance

    Absolute change in arterial volume for a change in pressure

    up to 12 months

Study Arms (3)

Healthy Controls

EXPERIMENTAL

Exercise MRI

Diagnostic Test: Exercise MRI

Aneurysm Being Monitored

EXPERIMENTAL

Exercise MRI

Diagnostic Test: Exercise MRI

Pre-operative Aneurysm Patients

EXPERIMENTAL

Exercise MRI

Diagnostic Test: Exercise MRI

Interventions

Exercise MRIDIAGNOSTIC_TEST

Exercise stress MRI with ergometer

Aneurysm Being MonitoredHealthy ControlsPre-operative Aneurysm Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Deborah Kwon, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Putnam

CONTACT

740-701-8226putnamj2@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

November 23, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)