Cardiac MRI for Heart Disease

(SPINS2 Trial)

Overseen By Bobby Heydari, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Vasodilators

Disqualifiers: Acute myocardial infarction, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 visit

1000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Vasodilator in treating heart disease?

The research suggests that vasodilators, when used in conjunction with cardiac MRI, can help assess heart function and blood flow, which is valuable in diagnosing and managing heart conditions like atrial fibrillation and ischemic heart disease. ^{1 2 3 4 5}

Is cardiac MRI safe for humans?

Cardiac MRI is generally safe and non-invasive, but certain metal and electronic devices may not be compatible, and some people might experience discomfort due to claustrophobia or difficulty holding their breath. Gadolinium-based contrast agents used in MRI are usually safe, but they can have rare side effects, and vasodilators like regadenoson used in stress tests are also considered safe. ^{3 6 7 8 9}

How does the vasodilator treatment differ from other heart disease treatments?

The vasodilator treatment is unique because it is assessed using cardiac MRI, a noninvasive imaging technique that provides detailed information about heart function and structure without exposing patients to radiation. This approach allows for precise evaluation of how the vasodilator affects blood flow and heart function, which is not typically available with other heart disease treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

Eligibility Criteria

This trial is for individuals experiencing chest pain or shortness of breath, who may have heart problems like blocked coronary arteries. Participants should be suitable for cardiac MRI tests and willing to undergo stress testing that simulates exercise.

Inclusion Criteria

I am between 35 and 85 years old.

I experience chest pain or have an ECG suggesting heart disease.

I am at high risk for heart disease due to my age, health conditions, family history, or lifestyle.

Exclusion Criteria

Active pregnancy

I have a serious heart condition not related to blocked arteries.

Metallic device or object that poses a magnetic resonance imaging safety hazard

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants have demographics and imaging characteristics recorded at baseline visits

1 visit

1 visit (in-person)

Treatment

Participants receive standardized quantitative stress cardiac magnetic resonance imaging protocol with Gadavist and vasodilator stress

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up via email or telephone at 3, 12, and 24 months

24 months

3 visits (virtual)

Treatment Details

Interventions

• Vasodilator

Trial Overview The study compares detailed blood flow measurements using cardiac MRI during a simulated stress state with standard imaging techniques to diagnose heart disease more accurately.

Participant Groups

Group I: New Myocardial Blood Flow Evaluation Experimental Treatment 4 Interventions

Quantitative + Qualitative stress cardiac magnetic resonance imaging.

Group II: Standard Myocardial Blood Flow Evaluation Active Control 4 Interventions

Qualitative stress cardiac magnetic resonance imaging only.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

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]

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 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]

Cardiovascular magnetic resonance (CMR) is becoming essential in cardiology, providing precise assessments of heart function and structure, particularly for conditions like ischemic heart disease and heart failure.

The growing accessibility and expertise in CMR outside specialized centers enhance patient care by allowing for detailed evaluations, including unique assessments like myocardial iron overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. Valbuena-López, S., Hinojar, R., Puntmann, VO.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Quantification of global myocardial oxygenation in humans: initial experience. [2021]

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

Feasibility and Prognostic Value of Vasodilator Stress Perfusion CMR in Patients With Atrial Fibrillation. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Contrast agents used in cardiovascular magnetic resonance imaging: current issues and future directions. [2015]

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

Recent advances in cardiac magnetic resonance imaging. [2019]

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

Non-invasive cardiac evaluation in heart failure patients using magnetic resonance imaging: a feasibility study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Spain pubmed.ncbi.nlm.nih.gov

Safety of regadenoson for vasodilation in cardiac MRI stress tests. [2021]

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

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

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

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

11. Italy pubmed.ncbi.nlm.nih.gov

[Clinical applications of cardiac magnetic resonance imaging: coronary heart disease, myocarditis, pericardial diseases, arrhythmias, valvular heart disease, congenital heart disease and cardiac masses]. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. [2017]

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

Valvular and hemodynamic assessment with CMR. [2011]

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

Coronary flow reserve: noninvasive measurement in humans with breath-hold velocity-encoded cine MR imaging. [2013]