Diagnostic Imaging for Coronary Heart Disease

(SWAN Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Vasospastic agents

Disqualifiers: Obstructive CAD, IVUS/MRI contraindication, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using a vasospastic agent (a medication that can cause blood vessels to spasm).

What data supports the effectiveness of the treatment Intravascular ultrasound, MRI, Magnetic Resonance Imaging for Coronary Heart Disease?

MRI is a valuable tool for diagnosing coronary heart disease as it can detect heart damage, assess heart function, and visualize blood flow without using radiation. Intravascular MR imaging offers high-resolution images and can guide cardiovascular treatments, making it a promising method for managing heart disease. ^{1 2 3 4 5}

Is diagnostic imaging for coronary heart disease, like MRI, safe for humans?

MRI is generally safe for humans, but it requires careful screening, especially for those with cardiovascular devices. Some rare side effects can occur, and certain conditions like claustrophobia or having metal implants may affect safety and comfort. ^{6 7 8 9 10}

How is the treatment using intravascular ultrasound and MRI different from other treatments for coronary heart disease?

This treatment is unique because it uses intravascular MRI, which provides high-resolution images of the coronary arteries without exposing patients to radiation or requiring contrast agents. It allows for detailed assessment of plaque in the arteries and can guide interventions, offering a noninvasive and comprehensive approach to managing coronary heart disease. ^{1 3 5 11 12}

What is the purpose of this trial?

Approximately 600,000 women are treated for acute coronary syndrome (ACS) annually in the US. ACS includes heart attack and a milder form called unstable angina. Many of these women have angiograms of which 14-39% show no "significant" coronary artery disease (CAD, cholesterol plaque accumulation in arteries of the heart). The remaining majority of women with ACS have cholesterol plaque buildup which appears severe enough on angiography to limit blood flow to the heart. It is difficult to advise women with heart attacks and no major heart artery blockages on what to do if chest pain happens again. Additional studies are needed to find out why this sort of heart attack happens and to help doctors understand how to treat patients who have this problem in the best possible way. Some women with heart attacks who have no major blockage in heart arteries have cholesterol plaque in the arteries of the heart cannot be seen on angiography but can be seen using a newer technique called intravascular ultrasound (IVUS). IVUS involves creating pictures of the artery walls using ultrasound (sound waves) from within the artery itself. In some women without major heart artery blockage, heart attack is caused by low blood flow due to disease of smaller blood vessels which cannot be seen on angiography or IVUS. This problem can be found using magnetic resonance imaging (MRI), which can show blood flow to the heart. MRI may also be used to show where the heart has been damaged. The pattern of damage could suggest that a heart attack in a woman, who has no badly blocked heart arteries, happened for one (or more) of these reasons or another reason. The Study of Women with ACS and Non-obstructive CAD (SWAN) will use IVUS and MRI to help determine the reasons for heart attacks in women with no major blockages in heart arteries.

Research Team

Harmony Reynolds, M.D.

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for women who have had a heart attack or unstable angina and are scheduled for an angiography, but do not have major blockages in their heart arteries. Women with previous obstructive coronary artery disease, those who can't undergo IVUS or MRI procedures, or those using vasospastic agents cannot participate.

Inclusion Criteria

I am a woman with heart issues scheduled for a heart vessel check.

Exclusion Criteria

I have been diagnosed with blocked arteries in my heart.

You cannot have an intravascular ultrasound (IVUS) or magnetic resonance imaging (MRI) for medical reasons.

I am taking medication for blood vessel spasms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo IVUS and MRI to determine the reasons for heart attacks in women with no major blockages in heart arteries

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

4 weeks

Treatment Details

Interventions

• Intravascular ultrasound
• MRI

Trial Overview The study uses intravascular ultrasound (IVUS) to take pictures of the inside of arteries and magnetic resonance imaging (MRI) to assess blood flow and damage in the heart. It aims to understand why some women experience heart attacks despite having no significant blockage in their arteries.

Participant Groups

Group I: Women Experimental Treatment 2 Interventions

IVUS and MRI performed in women with no obstructive CAD at angiography

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Findings from Research

Cardiovascular MRI is a noninvasive imaging technique that provides high-resolution, three-dimensional images of the heart, making it an effective tool for diagnosing cardiovascular diseases without exposing patients to ionizing radiation.

This imaging method allows for the differentiation between infarcted and non-infarcted heart tissue and enables the quantification of heart function and blood flow, highlighting its utility in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging: cardiological diagnosis]. Buser, PT.[2006]

Magnetic resonance (MR) imaging has become a valuable tool in medical imaging, but its safety in patients with cardiovascular devices requires careful consideration and screening.

Extensive data from ex vivo, animal, and clinical studies provide guidelines for safely performing MR examinations in these patients, emphasizing the need for thorough patient assessment and risk-benefit analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Levine, GN., Gomes, AS., Arai, AE., et al.[2016]

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]

Cardiac MRI is safe for critically ill infants with congenital heart disease, showing low risk and minimal hemodynamic changes during the procedure, as evidenced by a study of 20 patients in the pediatric cardiac intensive care unit.

The imaging provided crucial information that led to surgical or catheter interventions in 70% of the cases, highlighting its clinical utility in guiding management decisions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? Sarikouch, S., Schaeffler, R., Körperich, H., et al.[2021]

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.

The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

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]

References

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[Magnetic resonance imaging: cardiological diagnosis]. [2006]

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

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4. Ireland pubmed.ncbi.nlm.nih.gov

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

Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. [2016]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021]

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

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

11. China pubmed.ncbi.nlm.nih.gov

High-resolution intravascular magnetic resonance imaging of the coronary artery wall at 3.0 Tesla: toward evaluation of atherosclerotic plaque vulnerability. [2022]

12. Poland pubmed.ncbi.nlm.nih.gov

[Use of magnetic resonance in the diagnostics of ischemic heart disease]. [2015]