Exercise MRI for Aortic Aneurysm

Overseen By Jonathan Putnam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Cardioprotective medication

Disqualifiers: Congenital heart diseases, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how exercise affects individuals with aortic aneurysms, which are bulges in the aorta, the body's main artery. Researchers use exercise MRI scans, a type of imaging test, to observe aortic function during physical activity. This helps doctors understand safe exercise levels for these patients. Potential participants include those with an aortic aneurysm under monitoring or awaiting surgery, as well as healthy individuals without heart issues for comparison. Participants should not have metal implants or severe claustrophobia and must be able to pedal a bike while lying down. As an unphased trial, this study provides a unique opportunity to contribute to understanding safe exercise practices for those with aortic aneurysms.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, healthy controls cannot use cardioprotective medication. It's best to discuss your specific medications with the trial team.

What prior data suggests that Exercise MRI is safe for aortic aneurysm patients?

Research has shown that exercise is generally safe for people with aortic aneurysms, especially at a moderate level. One study found that moderate exercise is safe and feasible for many individuals with thoracic aortic aneurysms, which are bulges in the aorta, the body's largest artery. Another review found that moderate physical activity is usually safe and might even benefit those with small abdominal aortic aneurysms.

In these studies, exercise did not significantly increase the risk of complications. With the right intensity, exercise can be a safe way to help manage aortic aneurysms. This trial uses Exercise MRI, which combines exercise with imaging to study the heart and blood vessels. While this specific use is new, existing research strongly supports the safety of moderate exercise for aneurysm patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Exercise MRI for aortic aneurysms because it offers a new way to monitor the condition dynamically. Unlike traditional imaging methods that only capture static images, Exercise MRI allows doctors to see how the aorta behaves under stress, potentially spotting issues that might not be apparent at rest. This could lead to earlier interventions and more personalized treatment plans, improving patient outcomes.

What evidence suggests that Exercise MRI is effective for monitoring aortic aneurysm?

Studies have shown that exercise can benefit people with aortic aneurysms, as it might not cause the aorta to enlarge. Research suggests that physical activity can reduce inflammation and improve blood pressure, both crucial for heart health. However, more information is needed about exercise's effects on aneurysms. This trial uses Exercise MRI to observe the aorta's response during exercise, which could help determine safe exercise levels for individuals with aneurysms. Early findings indicate that exercise might enhance some heart health indicators, but further research is necessary to confirm these benefits specifically for aneurysm patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Deborah Kwon, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients with aortic aneurysm, specifically those who can safely undergo exercise and cardiac MRI (CMR) tests. The exact inclusion criteria are not provided, but typically participants should be stable enough to perform exercise under supervision.

Inclusion Criteria

I am 18 or older and need elective surgery for an aortic aneurysm at CCF.

I am over 18 and have no history of heart disease, high blood pressure, diabetes, or high cholesterol.

I am over 18, have an aneurysm that hasn't been operated on, and no past surgery for it.

Exclusion Criteria

I am not on heart-protecting meds and do not have a two-flap aortic valve.

Contra-indication for MRI including heart pacemaker/defibrillator, electronic/implanted stimulators or devices, cochlear implant or other ear implants, implanted drug pumps, programmable shunt, aneurysm clips and coils, stents not located in the heart, filters, metal fragment in the body or eye, congenital heart diseases, presence of A-V fistula or intracardiac shunts, moderate or severe dysfunction in multiple valves, significant claustrophobia, inability to pedal a supine bicycle, requirement for supplemental oxygen

I am being treated for an aneurysm and haven't had a traumatic aortic rupture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise MRI Assessment

Participants undergo exercise MRI to evaluate aortic blood flow, compliance, distensibility, and other mechanical properties during exercise

12 months

Regular visits for MRI assessments

Follow-up

Participants are monitored for safety and effectiveness after MRI assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise MRI

Trial Overview

The study uses exercise combined with Cardiac MRI to evaluate the effects of physical activity on the aorta's function and elasticity in patients with aortic aneurysm. It aims to establish safe levels of exercise by correlating CMR data with biomechanical properties of the aorta.

How Is the Trial Designed?

Group I: Pre-operative Aneurysm Patients Experimental Treatment 1 Intervention

Exercise MRI

Group II: Healthy Controls Experimental Treatment 1 Intervention

Exercise MRI

Group III: Aneurysm Being Monitored Experimental Treatment 1 Intervention

Exercise MRI

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study of 728 patients and 25 volunteers, regadenoson stress cardiac magnetic resonance (CMR) was found to be safe, with no serious adverse events like death or myocardial infarction reported.

The most common side effects were mild, including dyspnoea (30%), chest discomfort (27%), and headache (15%), indicating that while some patients experienced discomfort, the overall tolerability of regadenoson CMR is high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. Nguyen, KL., Bandettini, WP., Shanbhag, S., et al.[2021]

Magnetic resonance flow imaging and computational analysis can help understand the blood flow and inflammation in small abdominal aortic aneurysms (AAAs), which is crucial for developing effective treatments.

Supervised exercise training may be a promising first-line therapy for managing small AAAs, as current medical therapies have not been effective in slowing their progression before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAA disease: mechanism, stratification, and treatment. Dalman, RL., Tedesco, MM., Myers, J., et al.[2006]

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

In a study of 25 patients with ascending aortic aneurysm, functional MRI effectively measured aortic wall distensibility and pulse wave velocity, revealing that patients with aortic diameters over 50 mm had significantly decreased distensibility.

There was a strong inverse correlation between aortic distensibility and pulse wave velocity, indicating that as the aorta becomes less elastic, the speed of blood flow increases, which could help in assessing the severity of aortic aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Distensibility and Stiffness of Ascending Aortic Aneurysm using Magnetic Resonance Imaging. Tiwari, KK., Bevilacqua, S., Aquaro, G., et al.[2018]

In a study of 262 patients with abdominal aortic aneurysms over 4 cm in diameter, treadmill exercise stress testing was found to have a very low event rate for aneurysm rupture at just 0.4%.

The testing was deemed safe, as there were no deaths or significant negative outcomes reported, suggesting that exercise stress testing can be performed with minimal risk in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of treadmill exercise stress testing in patients with abdominal aortic aneurysms. Best, PJ., Tajik, AJ., Gibbons, RJ., et al.[2019]

In a study of 17,848 individuals with cardiac implantable electronic devices (CIEDs), only 0.3% underwent MRI scans, highlighting the rarity of MRI use in this population.

Among those who had MRIs, serious adverse events were extremely rare, suggesting that MRI can be safely performed in patients with MRI-compatible CIEDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging in People With Cardiac Implantable Electronic Devices: A Population Based Cohort Study. Gillam, MH., Inacio, MCS., Pratt, NL., et al.[2018]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

In a study involving 11 young, healthy subjects, exercise significantly increased heart rate and total blood flow through the abdominal aorta, demonstrating the body's adaptive response to physical activity.

During exercise, blood flow to the digestive and renal circulations decreased, while infrarenal blood flow surged, indicating a redistribution of blood flow to support active muscles, along with a notable increase in wall shear stress in both the supraceliac and infrarenal aorta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo quantification of blood flow and wall shear stress in the human abdominal aorta during lower limb exercise. Taylor, CA., Cheng, CP., Espinosa, LA., et al.[2019]

In a systematic review of five clinical trials involving patients with asymptomatic aortic aneurysm, exercise was found to be safe, with no exercise-related deaths or aortic ruptures reported.

While exercise did not significantly affect the rate of aneurysm expansion over 12 weeks to 12 months, it did reduce severe renal and cardiac complications and the length of hospital stays, suggesting potential benefits in preoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of structured exercise vs. no exercise for asymptomatic aortic aneurysm: systematic review and meta-analysis. Oliveira, RÁ., Nakajima, E., de Vasconcelos, VT., et al.[2021]

In a study of 15 patients with repaired coarctation of the aorta (CoA), exercise capacity (measured as VO2max) was positively correlated with changes in secondary flow characteristics like peak vorticity and wall shear stress during exercise, indicating that these flow patterns may be important biomarkers for exercise intolerance.

Traditional pressure gradient measurements did not correlate with exercise capacity, suggesting that assessing secondary flow dynamics through 4D flow cardiovascular magnetic resonance (CMR) could provide better insights into aortic arch geometry and its impact on long-term outcomes after CoA repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered hemodynamics by 4D flow cardiovascular magnetic resonance predict exercise intolerance in repaired coarctation of the aorta: an in vitro study. Mandell, JG., Loke, YH., Mass, PN., et al.[2021]

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