1000 Participants Needed

Cardiac MRI for Heart Disease

(SPINS2 Trial)

Recruiting at 3 trial locations
RY
BH
Overseen ByBobby Heydari, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether detailed heart scans can diagnose heart disease more effectively than regular scans. It uses a vasodilator, a medication that widens blood vessels, to observe blood flow to the heart during stress, such as exercise. Individuals who frequently experience chest pain or shortness of breath and have been advised they might have heart disease could be suitable candidates. The trial includes two groups: one receiving detailed scans and the other receiving standard scans. As an unphased trial, this study provides a unique opportunity to advance heart disease diagnosis techniques.

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 prior data suggests that cardiac MRI is safe for diagnosing heart disease?

Research has shown that using a vasodilator, a medicine that widens blood vessels, during a heart MRI is safe. One study found stress cardiac MRI to be safe and effective in predicting major heart problems in patients with heart failure. Another review highlighted the benefits of assessing blood flow in the heart during these tests.

These findings suggest that the vasodilator used in this study is well-tolerated. No major safety issues emerged in these studies, indicating that this method is generally considered safe for participants in a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to evaluate myocardial blood flow using cardiac MRI. Unlike the standard qualitative approach, this new method combines both quantitative and qualitative stress cardiac magnetic resonance imaging, potentially offering more detailed insights into heart health. By providing a more comprehensive view of blood flow in the heart, this technique could improve the accuracy of diagnosing heart disease, leading to better treatment decisions.

What evidence suggests that this trial's methods could be effective for diagnosing heart disease?

Research has shown that using certain medications called vasodilators with heart MRI scans effectively assesses heart function. In this trial, participants will undergo either a new myocardial blood flow evaluation or a standard one. Studies indicate that stress MRI, which uses a vasodilator to simulate exercise, helps identify heart problems. This method predicts major heart events, such as heart attacks, in people with heart failure. It also safely measures the severity of heart disease by accurately assessing blood flow. Overall, this approach is reliable and adds value to heart health checks.13678

Are You a Good Fit for This Trial?

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
See 4 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: New Myocardial Blood Flow EvaluationExperimental Treatment4 Interventions
Group II: Standard Myocardial Blood Flow EvaluationActive Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

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.
[Magnetic resonance imaging: cardiological diagnosis].Buser, PT.[2006]
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.
Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications.Barison, A., Baritussio, A., Cipriani, A., et al.[2021]
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.
Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation.Valbuena-López, S., Hinojar, R., Puntmann, VO.[2017]

Citations

Vasodilator Myocardial Perfusion Cardiac Magnetic ...(1) This meta-analysis takes historical studies into account using either DSE or pCMR that compared the functional test results to that of invasive or coronary ...
SCMR Expert Consensus Statement on Quantitative ...The aim of this Society for Cardiovascular Magnetic Resonance (SCMR) expert consensus document is to provide recommendations for the acquisition ...
Stress Cardiac Magnetic Resonance Myocardial Perfusion ...This paper reviews the basics principles of stress CMR, the data supporting its clinical use, the added-value of myocardial blood flow ...
Safety and Prognostic Value of Vasodilator Stress ...Stress CMR is safe and has a good discriminative prognostic value to predict the occurrence of MACE in patients with HFrEF.
Diagnostic and Prognostic Value of Stress Cardiovascular ...This systematic review and meta-analysis assesses the diagnostic accuracy and prognostic value of stress cardiovascular magnetic resonance ...
Stress Cardiac Magnetic Resonance Myocardial Perfusion ...In this article, we review the basics principles of stress CMR, the data supporting its clinical use, the added-value of myocardial blood flow quantification, ...
Quantitative Stress First-Pass Perfusion Cardiac MRIQuantitative stress perfusion (qPerf) cardiac magnetic resonance (CMR) imaging is a noninvasive approach used to quantify myocardial blood flow (MBF).
Clinical Quantification of Myocardial Blood Flow Using PETThe purpose of this document is, first, to consolidate and update technical considerations for clinical quantification of MBF and myocardial flow reserve (MFR)
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security