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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores why some women experience heart attacks without major artery blockages. It employs two imaging techniques—IVUS, an ultrasound from inside the artery, and MRI, which shows blood flow and heart damage. The goal is to improve understanding and treatment of these heart attacks. Eligible women have had a recent heart attack or chest pain, are scheduled for an angiogram, and have no history of major artery blockage. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance diagnosis and treatment options for women with heart conditions.

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 prior data suggests that these diagnostic imaging techniques are safe for women with coronary heart disease?

Research has shown that intravascular ultrasound (IVUS) is a safe and well-tolerated procedure, often used in heart procedures to provide a clearer view of the arteries. One study found that using IVUS to guide certain heart treatments reduced long-term problems, indicating its safety in diagnosing heart issues.

MRI (magnetic resonance imaging) is also considered very safe, offering detailed images of the heart without exposing patients to harmful radiation. Although older machines raised concerns, modern MRIs have very few serious side effects when safety guidelines are followed, making MRI a reliable method for heart imaging.

Overall, both IVUS and MRI have strong safety records, making them good options for understanding heart conditions in women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intravascular ultrasound (IVUS) and MRI for diagnosing coronary heart disease because these imaging techniques offer a more detailed view of the heart and blood vessels than traditional methods like angiography. Unlike standard options that primarily focus on identifying blockages, IVUS and MRI can provide insights into the structure and composition of artery walls and detect issues that aren't visible with other techniques. This approach could improve the accuracy of diagnoses, especially in women who may not show obstructive coronary artery disease in standard tests, potentially leading to better-targeted treatments.

What evidence suggests that intravascular ultrasound and MRI are effective for diagnosing coronary heart disease in women?

This trial studies the effectiveness of intravascular ultrasound (IVUS) and magnetic resonance imaging (MRI) in diagnosing coronary heart disease in women without obstructive coronary artery disease at angiography. Research has shown that IVUS improves heart health by providing a clear view of the heart's arteries, even when regular methods fail. This technique excels at identifying issues in the heart's small vessels and guiding treatment effectively. MRI is also valuable for heart care, regarded as the best method for assessing heart function and detecting problems that other tests miss. It is particularly useful in identifying hidden heart damage and understanding why heart attacks occur without obvious blockage. Both IVUS and MRI offer crucial insights that help doctors treat heart conditions more accurately. ^{6 7 8 9 10}

Who Is on the Research Team?

Harmony Reynolds, M.D.

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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