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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Exercise MRI for Aortic Aneurysm?

Research shows that while exercise does not reduce the growth rate of aortic aneurysms, it can lower the risk of severe complications and shorten hospital stays. Additionally, MRI techniques can help monitor blood flow and aortic conditions during exercise, potentially aiding in the management of aortic aneurysms. ^{1 2 3 4 5}

Is Exercise MRI generally safe for humans?

Research on MRI, including studies with contrast agents and in people with heart conditions, shows that adverse events are rare. For example, in a study of 72,839 patients, acute adverse events were uncommon, and another study found that serious events were rare even in people with heart devices. ^{6 7 8 9 10}

How is the Exercise MRI treatment for aortic aneurysm different from other treatments?

Exercise MRI is unique because it uses magnetic resonance imaging (MRI) to assess blood flow and aortic conditions during exercise, potentially identifying early signs of exercise intolerance and guiding treatment decisions. Unlike traditional treatments that focus on surgical repair, this approach may help in monitoring and managing small aneurysms through non-invasive imaging and exercise. ^{1 2 4 5 11}

Research Team

Deborah Kwon, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The safety of treadmill exercise stress testing in patients with abdominal aortic aneurysms. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

In vivo quantification of blood flow and wall shear stress in the human abdominal aorta during lower limb exercise. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of structured exercise vs. no exercise for asymptomatic aortic aneurysm: systematic review and meta-analysis. [2021]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

AAA disease: mechanism, stratification, and treatment. [2006]

6. Germany 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. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging in People With Cardiac Implantable Electronic Devices: A Population Based Cohort Study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]

11. Nepal pubmed.ncbi.nlm.nih.gov

Evaluation of Distensibility and Stiffness of Ascending Aortic Aneurysm using Magnetic Resonance Imaging. [2018]